COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND

TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY
UNDER SPINAL ANAESTHESIA

A Thesis submitted to
BABA FARID UNIVERSITY OF HEALTH SCIENCES FARIDKOT
IN THE PARTIAL FULFILLMENT
For the Award of Degree of
M.D. (ANAESTHESIOLOGY)

IN
ANAESTHESIOLOGY AND INTENSIVE CARE

2022
Submitted By
DR. DIPAK SINGH

DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE,

GOVT. MEDICAL COLLEGE, AMRITSAR

i
 DECLARATION BY THE CANDIDATE

I hereby declare that the thesis entitled “COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR CONTROL
OF POST OPERATIVE SHIVERING AFTER SURGERY UNDER
SPINAL ANAESTHESIA” submitted towards partial fulfillment of the
requirements for the award of M.D. (Anaesthesiology) degree to
BFUHS is a compilation of original work carried out by me under the
supervision of Dr. Joginder Pal Attri, Professor, Dr. Rajan Kumar,
Professor, Department of Anaesthesiology & Intensive Care Unit, Govt.
Medical College, Amritsar. No part of this thesis has formed the basis for
the award of any degree previously.

Signature of Candidate

DR. DIPAK SINGH

Department of Anaesthesiology & Intensive Care Unit,
Govt. Medical College,
Amritsar

Date:
Place:

ii
 CERTIFICATE OF SUPERVISOR

This is to certify that the work incorporated in this thesis entitled

“COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE AND
TRAMADOL FOR CONTROL OF POST OPERATIVE SHIVERING
AFTER SURGERY UNDER SPINAL ANAESTHESIA” has been carried
out by Dr. Dipak Singh under our direct supervision. The data
incorporated in this thesis is original and genuine and has been carried out
by the candidate himself.

DR. JOGINDER PAL ATTRI DR. RAJAN KUMAR

M.D., M.D.,
Professor, Professor,
Department of Anaesthesiology & Department of Anaesthesiology &
Intensive Care, Intensive Care,
Government Medical College, Government Medical College,
Amritsar Amritsar

(Supervisor) (Co-Supervisor)

DATE:………………

iii
 ENDORSEMENT BY THE HEAD OF THE INSTITUTION

This is to certify that the thesis entitled “COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR CONTROL
OF POST OPERATIVE SHIVERING AFTER SURGERY UNDER
SPINAL ANAESTHESIA” is a bonafide research work done by
Dr. Dipak Singh under the supervision of Dr. Joginder Pal Attri,
Professor, Dr. Rajan Kumar, Professor, Department of Anaesthesiology
& Intensive Care Unit in this institution.

Signature
Head of Institute (Director Principal)

DATE:…………….

iv
 ENDORSEMENT BY THE HEAD OF THE DEPARTMENT

This is to certify that the thesis entitled “COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR CONTROL
OF POST OPERATIVE SHIVERING AFTER SURGERY UNDER
SPINAL ANAESTHESIA” is a bonafide research work done by
Dr. Dipak Singh under the supervision of Dr. Joginder Pal Attri,
Professor, Dr. Rajan Kumar, Professor, Department of Anaesthesiology
& Intensive Care Unit in this institution.

DR. VEENA CHATRATH,

M.D.,
Director Principal,
Professor and Head,
Department of Anaesthesiology & Intensive Care Unit,
Govt. Medical College, Amritsar

Place: AMRITSAR

Dated:

v
 COPYRIGHT

Declaration by the Candidate

I hereby declare that the Baba Farid University of Health Sciences,
Faridkot, shall have the rights to preserve & use this thesis in print or
electronic format for academic/study purpose by the research
scholar/students.

Signature
Dr. Dipak Singh
Department of Anaesthesiology & Intensive Care Unit,
Govt. Medical College,
Amritsar

DATE:

© Baba Farid University of Health Sciences, Faridkot

vi
 Acknowledgements

It is most appropriate that I begin by expressing my undying gratitude to the Almighty

God for giving me strength both mentally and physically to complete this task.At the end of my
thesis work, it is a pleasant task to express my thanks to all those whocontributed in many ways
to make this possible and made it an unforgettable experiencefor me.

I would like to express my deep sense of gratitude to respected guide and supervisor,
Dr. Joginder Pal Attri, Professor, Department of Anaesthesia and Intensivecare, Government
Medical College, Amritsar for his sagacious guidance, constructive criticism, professional
expertise, prudent counsel and moral support throughout the course of this study. I am indebted
to his for giving me golden opportunity to perform this study. His guidance and advice carried
me though all stages of writing my thesis. He has been my constant inspiration. Without his
constant feedback, this thesis work would not have been achievable. I will be forever grateful
to him for his support and kindness.

With utmost sense of regard, I express my indebtedness to my co-supervisor Dr. Rajan

Kumar, Professor, Department of Anaesthesia, Government Medical College, Amritsar for his
constant encouragement, invaluable guidance,immense patience, great care and attention to
detail that he has shown throughout thecourse of this study. He provided with encouraging and
constructive feedback, valuable comments and suggestions. He has been a friend, authority and
guide, all rolled into one person.

Words are inadequate in expressing my deep sense of gratitude towards for his continued
and unfailing love, support and understanding that made the completion of my thesis possible;
my parents, Sh. Ram Chandra Mondal and Smt. Sunaiyana Devi for giving up so much to make
my career a priority in their lives for being my rock.

It would have been impossible to complete this task but for the love, encouragement and
inspiration of Dr. Rishabh, Dr. Harmanjot, Dr. Mehakamrit,Dr. Harjot Singh, Dr. Priyanka,
Dr. Aishwarya, Dr. Harpreet, a n d Dr. Anamika, who were always with me at any times of
need. Thank you all, for always being there for me. I am thankful to my colleagues and friends
in the Department of Anaesthesia, Government Medical College, Amritsar for giving me utmost
co-operation.

vii
 I am also thankful to Sh. Ramesh Rajpoot (Billa), Mr. Sunil Rajpoot, Mrs. Kavita
Rajpoot, Mr. Aryan Sharma and Mr. Raj kumar of Billa Computers for typing this manuscript
with sincerity and dedication.

Last but not least, without the patients' involvement, this dissertation would not have
been feasible. I am very grateful to them for their collaboration. Above all, I want to express my
gratitude to God the Almighty for helping me to complete my task. And last, I'm responsible for
any remaining mistakes and flaws.

Amritsar

Dated: _________
(Dr. Dipak Singh)

viii
 TABLE OF CONTENTS

S. NO. PARTICULARS PAGE NO.

1. INTRODUCTION 1

2. PHARMACOLOGY 13

3. REVIEW OF LITERATURE 27

4. AIMS & OBJECTIVES 33

5. MATERIALS AND METHODS 34

6. OBSERVATIONS AND RESULTS 39

7. DISCUSSION 61

8. SUMMARY 73

9. LIMITATIONS 75

10. CONCLUSION 76

11. BIBLIOGRAPHY 77

12. APPENDIX-I Master chart

13. APPENDIX-II Plan of thesis

ix
 LIST OF TABLES

Sr. PAGE
TITLE
No. NO.

1. AGE GROUP IN YEARS 39

2. MEAN AGE 40

3. SEX WISE DISTRIBUTION 42

4. DISTRIBUTION OF PATIENT ACCORDING TO ASA GRADE 43

DISTRIBUTION ACCORDING TO SURGICAL PROCEDURE

5. 44
PERFORMED

6. TIME OF ONSET OF SHIVERING (MINUTES) 45

7. SHIVERING CONTROL 46

TIME TAKEN BY THE DRUG TO CONTROL OF SHIVERING

8. 47
(IN MINUTES)

9. SEDATION SCORE (FILOS) 48

10. INCIDENCE OF NAUSEA AND VOMITING 49

11. INCIDENCE OF BRADYCARDIA 50

12. INCIDENCE OF HYPOTENSION 51

13. RECURRENCE OF SHIVERING 52

MEAN HEART RATE (per minutes) AT DIFFERENT TIME

14. 53
INTERVAL

MEAN SYSTOLIC BLOOD PRESSURE (mmHg) AT

15. 55
DIFFERENT TIME INTERVAL

MEAN DIASTOLIC BLOOD PRESSURE (mmHg) AT

16. 57
DIFFERENT TIME INTERVAL

17. MEAN SpO2 AT DIFFERENT TIME INTERVAL 59

x
 LIST OF GRAPHS

Sr. PAGE
TITLE
No. NO.

1. AGE GROUP IN YEARS 39

2. MEAN AGE 40

3. SEX WISE DISTRIBUTION 42

4. DISTRIBUTION OF PATIENT ACCORDING TO ASA GRADE 43

DISTRIBUTION ACCORDING TO SURGICAL PROCEDURE

5. 44
PERFORMED

6. TIME OF ONSET OF SHIVERING (MINUTES) 45

7. SHIVERING CONTROL 46

TIME TAKEN BY THE DRUG TO CONTROL OF SHIVERING

8. 47
(IN MINUTES)

9. SEDATION SCORE (FILOS) 48

10. INCIDENCE OF NAUSEA AND VOMITING 49

11. INCIDENCE OF BRADYCARDIA 50

12. INCIDENCE OF HYPOTENSION 51

13. RECURRENCE OF SHIVERING 52

MEAN HEART RATE (per minutes) AT DIFFERENT TIME

14. 54
INTERVAL

MEAN SYSTOLIC BLOOD PRESSURE (mmHg) AT

15. 56
DIFFERENT TIME INTERVAL

MEAN DIASTOLIC BLOOD PRESSURE (mmHg) AT

16. 58
DIFFERENT TIME INTERVAL

17. MEAN SpO2 AT DIFFERENT TIME INTERVAL 60

xi
 LIST OF FIGURES

PAGE
Sr. No. FIGURES
NO.
RELATIONSHIP BETWEEN MEAN SKIN
1. TEMPERATURE AND CORE TEMPERATURE 4
TRIGGERING VASOCONSTRICTION AND SHIVERING
2. INTERTHRESHOLD TEMPERATURE RANGE 5
SPINAL ANAESTHESIA INCREASED THE SWEATING
3. THRESHOLD BUT DECREASED THE SHIVERING AND 6
VASOCONSTRICTION THRESHOLDS
THE NUMBER OF DERMATOMES BLOCKED VERSUS
SHIVERING THRESHOLD. THE SHIVERING
4. 7
THRESHOLD WAS DECREASED BY MORE EXTENSIVE
SPINAL BLOCKS
PATTERNS OF INTRAOPERATIVE HYPOTHERMIA
CORE TEMPERATURE CHANGES CHARACTERIZED
5. 8
BY A RAPID FALL FOLLOWED BY A SLOW FALL AND
THEN A PLATEAU PHASE BEING REACHED.
6. CHEMICAL STRUCTURE OF DEXMEDETOMIDINE 13
7. CHEMICAL STRUCTURE OF TRAMADOL 17
8. CHEMICAL STRUCTURE OF CLONIDINE 21

xii
 LIST OF ABBREVIATIONS

% : Percentage
µg : microgram
ASA : American Society of Anesthesiologist
BD : Twice a day
cAMP : Cyclic Adenosine Monophosphate
CNS : Central Nervous System
CO2 : Carbon Dioxide
CYP : Cytochrome
DBP : Diastolic Blood Pressure
G : Gauge
HR : Heart Rate
hrs : hours
IEC : Institutional Ethics Committee
IV : Intravenous
kg : kilogram
l : liters
MAC : Minimum Alveolar Concentration
MAOI : Monoamino Oxidase Inhibitor
mg : milligram
min : minutes
ml : milliliters
mmHg : millimeter of mercury
NSAIDS : Non Steroidal Anti-inflammatory Drugs
oC : Centigrade
OD : Once a day
oF : Fahrenheit
RR : Respiratory Rate
SBP : Systolic Blood Pressure
SD : Standard Deviation
spO2 : oxygen saturation
TDS : Thrice a day
Vd : Volume of Distribution
α : Alpha
δ : Delta

xiii
 INTRODUCTION

Shivering is a common and distressing experience to many patients which

occurs either during or immediately after the surgery. It is defined as an involuntary,
repetitive activity of skeletal muscles. The incidence of shivering varies but is very
high and the incidence is approximately 40 – 50%.1 Spinal anaesthesia is widely
used as safe anaesthesia technique for both elective and emergency operations
including all open gynaecology and obstetric surgery, orthopedic and plastic
surgery of lower limb and pelvis and majority of urological procedure.2

The main causes of shivering are heat loss, increased sympathetic tone,
pain and systemic release of pyrogens. Shivering during surgery leads to an
uncomfortable experience to the patient along with that leads to an increase in
oxygen consumption and carbon dioxide production by two to three fold. Shivering
can also increase catecholamine production, lactic acidosis, intraocular pressure,
intracranial pressure.3 Mild shivering increases oxygen consumption like that
produced by light exercise but severe shivering can increase oxygen consumption
and metabolic rate by 100 – 600%. This can prove detrimental to patients with
limited cardiac reserve. Shivering also creates difficulty in monitoring the patients
as most of the multi parameter monitors used for anaesthesia show erroneous
values.

Shivering is a physiological response to core heat production. The core body

temperature is maintained within range of 36.5-37.5o C which is known as thermo-
neutral zone. Thermo regulatory response like vasoconstriction and shivering are
activated when core body temperature falls below normal range.4 The spinal α
motor neurons and their axons mediate the neurological mechanism of shivering
with centre at pre-optic nucleus of the anterior hypothalamus.5

After spinal anaesthesia shivering is more common than after general

anaesthesia as vasoconstriction effect after heat loss during surgery is lost when
patient in under spinal anaesthesia due to sympathetic blockade.

1
 Mammals are homeothermic. They need a nearly constant internal body
temperature. Human core temperature normally ranges from 36.5 0C to 37.50C.
Anterior hypothalamus integrates thermal inputs from different tissues of the body
and compares peripheral information with a set point or threshold value.
Temperature lower than this set point will result in responses to warm the body
while temperatures higher will trigger reflexes to cool the body.6

In patients undergoing neuraxial anaesthesia, shivering is a normal

thermoregulatory mechanism as evidenced by the presence of vasoconstriction
before shivering.7 Spinal anaesthesia impairs the thermoregulatory system by
inhibiting vasoconstriction, which plays an important role in temperature regulation.8
Spinal anaesthesia results in redistribution of core heat to the periphery from the
trunk (below the level of block).9 Both these effects predispose patients undergoing
spinal anaesthesia to hypothermia and shivering.

Studies in recent years have shown that even mild hypothermia (10C – 20C)
can triple the incidence of adverse cardiac outcomes. An increase in surgical blood
loss and increase in need for blood transfusion by 20% is also noted. All these
factors leads to a prolonged hospitalization.

Normal body temperature is 36.5-37.5oC. Core body temperature is

maintained near a constant level through thermo regulation. However when
exposed to cold environment, the internal mechanism is unable to replenish heat
that is lost to the surroundings. Hypothermia is defined as any body temperature
below 35OC (95OF). It is subdivided as

 Mild (32-35OC)

 Moderate (28-32OC)

 Severe (20-28OC)

 Profound ( less than 20OC)

2
 Shivering is a bodily defense function in response to early hypothermia in
warm blooded animals. When the core temperature drops, the shivering reflex is
triggered.

NORMAL THERMOREGULATION

It is based on multiple signals from all types of tissue. Processing of signals

occurs in three phases, namely, 1) afferent thermal sensing, 2) central regulation
and 3) efferent responses.

I. AFFERENT INPUT

Information about temperature sensation is acquired from thermally (warm

and cold) sensitive cells all over the body. Cold receptors increase their firing rate
when temperature decreases whereas warm receptors do so when temperature
increases. The sensors for firing belongs mostly to a class of transient receptor
potential (TRP) protein receptors.10

Warm signals travels via unmyelinated C fibres and cold signals via Aδ nerve
fibres but there is a certain degree of overlap. Since C type fibres also carry pain
sensation, intense heat appears similar to sharp pain. Thermal signals pass through
spinothalamic tracts.11

The spinal cord, hypothalamus, other parts of brain , thoracic and deep
abdominal tissues, and skin surface contribute about 20% each of total thermal
input to the central regulatory system.12

II. CENTRAL CONTROL

Temperature regulation is done primarily by central structures, namely the

hypothalamus which integrates thermal inputs from skin surfaces and deep tissues
with thresholds for each thermal response. Preoptic region of anterior
hypothalamus is the most important autonomic thermoregulatory centre. Before
integration of thermal inputs, “pre processing” of these inputs is done in the spinal
cord and other areas of central nervous system. Some thermoregulatory responses
can be dealt by spinal cord itself.13

3
 The absolute threshold temperature is determined by the body which is
mediated by norepinephrine, dopamine, neuropeptides, 5- hydroxy tryptamine.

Thresholds vary based on sex, circadian rhythm, menstrual cycle, infection,

food intake, hypothyroidism or hyperthyroidism, exercise, anaesthetic and other
drugs like sedatives, alcohol and nicotine etc., Both vasoconstriction and sweating
thresholds are 0.30C– 0.50C lower in men than in woman. Central control is intact
even in premature infants. But, thermoregulatory control is slightly impaired in
elderly.14

Control of autonomic responses is 80% determined by thermal signals from

core structures.15 The interthreshold range (core temperatures not triggering
autonomic thermoregulatory responses) is only a few tenths of a degree centigrade.
It is bounded by sweating threshold at one end and that of vasoconstriction at the
other end. Humans normally maintain core temperatures tightly.

Figure 1: Relationship between mean skin temperature and core

temperature triggering vasoconstriction and shivering.

III. EFFERENT RESPONSES

Human body responds to temperature variations by various effector

mechanisms which changes heat production or changes environmental heat loss.

4
 Energy efficient receptors like vasoconstriction are initiated before shivering
occurs. The interthreshold range in humans is 0.2o C only.

Figure 2: Interthreshold temperature range

The most commonly used effector mechanism is cutaneous

vasoconstriction. Vasoconstriction reduces heat loss by convection and radiation.
Total digital skin blood flow can be divided into nutritional [mainly capillary] and
thermoregulatory [mainly arteriovenous shunt] components.16 The
thermoregulatory arteriovenous shunts vasoconstriction is mediated by local α –
adrenergic sympathetic nerves.

Non shivering thermogenesis increases heat production. The major sources

in adults are brown fat tissue and skeletal muscle. The metabolic rate is controlled
by nor epinephrine in both these tissues.

Behavioural regulation is the most important effector mechanism. It includes

modifying environmental temperature, warm blankets, voluntary movements and
assuming position that oppose skin surface. Behavioural compensation is irrelevant
during general anaesthesia as patients are unconscious and mostly paralysed.

On the other end of the spectrum, sweating is produced by postganglionic,

cholinergic nerve fibres.17 Vasodilation is mediated by nitric oxide.

5
NEURAXIAL ANAESTHESIA AND THERMOREGULATION

Autonomic thermoregulation is impaired during regional anaesthesia and

results in intra operative core hypothermia. Spinal and epidural anaesthesia, both
reduce the shivering and vasoconstriction thresholds above the level of the block
by about 0.60C. The shivering and vasoconstriction thresholds are comparably
decreased during regional anaesthesia18 indicating an alteration in central control.

Figure 3: Spinal anaesthesia increased the sweating threshold but

decreased the shivering and vasoconstriction thresholds.

The mechanism involving impairment in centrally mediated thermoregulation

via peripheral administration of local anaesthetic involves alteration in afferent
thermal inputs from legs. The key factor is that, tonic cold signals dominates thermal
input at normal legs skin temperature in typical operating room conditions. Regional
anaesthesia alters the thermal inputs from blocked regions which is primarily cold
information. Brain interprets this decreased cold information as relative leg
warming.

This is an unconscious process, as perceived temperature does not

increase.19 Since, skin temperature remains an important input to the
thermoregulatory system, leg warming proportionately decreases the shivering and
vasoconstriction thresholds. The reduction in thresholds is proportional to the
number of segments blocked.20

6
 Figure 4: The number of dermatomes blocked versus shivering threshold.
The shivering threshold was decreased by more extensive spinal blocks
Neuraxial anaesthesia is supplemented with sedatives which impairs
thermoregulatory control.21 This inhibition becomes severe when associated with
other factors like old age, pre-existing illness and also by neuraxial blockade.

Patient does not perceive cold during regional anaesthesia because

temperature sensation is largely determined by skin temperature and not by core
temperature. During regional anaesthesia, decrease in core temperature is
associated with an increase in skin temperature. This results in a feeling of
increased warmth associated with triggering of autonomic thermoregulatory
responses like shivering.8

Overall, neuraxial anaesthesia inhibits many aspects of thermoregulatory

control. Behavioural regulation is impaired. The shivering and vasoconstriction
thresholds are decreased. All these factors, results in triggering of cold defences at
a lower temperature than normal. Patients do not recognize that they are
hypothermic too. Defences are less effective even when it is triggered.

7
HYPOTHERMIA DURING GENERAL ANAESTHESIA

Heat may be transferred to the environment from the patient in four ways,
namely, conduction, radiation, convection and evaporation. Among these
mechanisms, convection and radiation appears to contribute most to perioperative
heat loss.

PATTERNS OF INTRAOPERATIVE HYPOTHERMIA

Figure 5: Patterns of intraoperative hypothermia core temperature changes

characterized by a rapid fall followed by a slow fall and then a plateau phase
being reached.
SHIVERING

Shivering is preceded by hypothermia and vasoconstriction. Shivering is an

involuntary muscular activity which increases metabolic heat production around
600% above basal level.22 Shivering can be elicited on cooling the preoptic region
of the hypothalamus. Shivering during regional anaesthesia can be treated by
warming sentient skin as this augments cutaneous thermal input to central
thermoregulatory system and so, increases the degree of core hypothermia
tolerated.

8
 Etiology of postanaesthesia shivering like tremors exists in two different
pattern.23 First is a tonic pattern similar to normal shivering typically at 4 – 8
cycle/min waxing and waning pattern. Second is a phasic, 5 to 7 Hz bursting pattern
like pathologic clonus.24 Both these tonic and phasic patterns are thermoregulatory
responses, characterized by the precedence of core hypothermia and
arteriovenous shunt vasoconstriction. It may be due to anaesthetic induced
disinhibition of descending spinal reflexes.

TEMPERATURE MONITORING

Temperature monitoring should be accurate. Mercury-in-glass thermometers

which were used earlier were cumbersome and so, now are replaced by electronic
systems. The most commonly used systems are thermistors and thermocouples.
Both these devices are accurate and are inexpensive. Infrared monitors used for
tympanic membrane temperature monitoring from outer ear are unreliable.25

Core temperature can be monitored at nasopharynx, distal part of the

oesophagus, tympanic membrane, pulmonary artery. The core thermal component
contains highly perfused tissues and the temperature is high when compared with
the rest of the body. Core temperature may be measured with accuracy using oral,
axillary or rectal temperatures also.

The objective of temperature monitoring is to detect changes in body temperature

during anaesthesia.

1. Core temperature to be monitored in patients under general anaesthesia for

greater than 30 minutes.

2. Temperature monitoring during regional anaesthesia to be done if adverse

changes in temperature expected.

3. Core temperature to be maintained greater than 360C unless hypothermia is

indicated.

9
 Measures to prevent shivering

I. Non pharmacological methods:

a) Passive insulators

Cotton blankets, surgical drapes, disposable plastic draps, plastic bags are
passive insulators which reduce heat loss to environment. Heat conservation is
directly proportional to area covered. A single layer covering material decreases
approximately 30% heat loss.

b) Active warming system

In convection warming system, when warmed air is forced though a quilt like
porous blanket covering the body, it replaces air envelope of normal body with a
warm air envelope. This is the most effective system for conservation of body heat.
Radiant heat system like infrared light, thermal ceiling lights are used for warming.
Other measures like warming inspired air, warming intravenous fluids, blood and
blood components before infusion. Maintaining post operative environment at 24 oC
are useful in preserving body temperature and reduce shivering.

II. Pharmacological methods:

The pharamacological methods include drugs like tramadol, clonidine,

dexmedetomidine etc. Tramadol is a synthetic opioid analgesic. It acts by inhibition
of re-uptake of serotonin and nor epinephrine and binding to µ type of opioid
receptor. Its analgesic potency is about one tenth that of morphine. Tramadol can
cause analgesia, nausea, vomiting, dizziness etc. At therapeutic doses, it has no
effect on heart rate and blood pressure. The antishivering action of tramadol is due
to serotonergic and noradrenergic receptor activity and also opioid receptor activity.

Clonidine is a centrally acting α receptors agonist. It exerts its anti-shivering

effects at three levels:- hypothalamus, locus coeruleus and spinal cord. At
hypothalamic level it decreases thermo-regulatory threshold for vasoconstriction
and shivering. It also reduces spontaneous firing in locus coeruleus. At spinal cord,
it activates α-2 receptors and release of dynorphine, nor epinephrine and

10
acetylcholine. It has better efficacy and lesser adverse side effects as compared to
tramadol but there was 5-10% incidence of hypotension and bradycardia with
clonidine.26

Dexmedetomidine acts by activation of α2 adrenoceptors located in the

presynaptic terminal and inhibits the release of norepinephrine. Activation of α2
adrenoceptors in the post synaptic terminal in the CNS inhibits sympathetic activity
and can cause sedation, anxiolysis, decreases shivering along with reduced heart
rate and blood pressure. α2 receptors inhibit adenylyl cyclase activity and result in
decreased intracellular cAMP levels. This inhibition of adenylyl cyclase activity is
transduced by the inhibitory regulatory protein G. It is effective in providing good
hemodynamic stability. Dexmedetomidine was faster in control of shivering as
compared to tramadol and clonidine (slowest in control of shivering).27

Consequences of hypothermia and shivering

1. Reversible coagulopathy

2. Increased blood loss

3. Increased blood transfusion

4. Impaired wound healing

5. Increased risk of infection

6. Delayed drug metabolism

7. Left shift of hemoglobin- oxygen dissociation curve

8. Increased peripheral vascular resistance

9. Increased myocardial oxygen consumption

10. Increased basal metabolic rate

11. Monitoring artefacts–shows aberrant values

11
 Since very few studies are available comparing these three drugs. Hence,
present study is designed to compare the effect of dexmedetomidine, clonidine and
tramadol to control post operative shivering after spinal anaesthesia.

12
 PHARMACOLOGY

DEXMEDETOMIDINE

Dexmedetomidine is an α2 adrenergic agonist. It produces sedation,

anxiolysis, hypnosis, analgesia and has anti shivering properties.
Dexmedetomidine is a highly selective agonist at α2 receptor with 1600 times
greater selectivity for the α2 receptor compared with the α 1 receptor.

Dexmedetomidine is a d-enantiomer of medetomidine, belonging to the

imidazole subclass of α2 receptor agonists. It has a high specificity for α2 receptor
(α2 :α1 1600:1), when compared to clonidine (α 2:α 1 200:1).

Figure 6: Chemical Structure of dexmedetomidine

PHARMACOKINETICS

Dexmedetomidine, the dextroisomer of medetomidine, is short acting with

linear concentration dependent kinetics

Distribution

The pharmacokinetics of dexmedetomidine is commonly described using a

two-compartment model .It is rapidly distributed after administration with a half life

13
of 6 minutes. The elimination half life is approximately 2 hours. Dexmedetomidine
is highly bound to plasma proteins (94%).28

Metabolism And Elimination

Dexmedetomidine is extensively metabolised in the liver through glucuronide

conjugation and biotransformation by the cytochrome P450 system without
formation of toxic metabolites. The resulting methyl and glucuronide conjugates are
excreted by the kidneys. Dexmedetomidine is metabolised by various metabolic
pathways. Direct N-glucuronidation to inactive metabolites accounts for 41% of
metabolism of dexmedetomidine. N-methylation to produce 3-hydroxy N-methyl-
dexmedetomidine is the next major pathway accounting for 21% of metabolism of
dexmedetomidine. Hydroxylation followed by conjugation is the other metabolic
pathway of dexmedetomidine. Renal and hepatic diseases greatly impair the
pharmacokinetic properties of dexmedetomidine. Hepatic impairment results in an
increase in the half-life of dexmedetomidine as well as a decrease in clearance and
protein binding. Renal dysfunction leads to a decrease in the elimination half-life,
however the volume of distribution and clearance are not affected.29

Molecular Weight 236.7 Daltons

Lipid solubility 30

Distribution t1/2 6 min

Protein Binding 94%

Volume of distribution 118 L

Elimination t1/2 120-180 min

Context sensitive half time 4 – 250 min

14
PHARMACODYNAMICS

Mechanism of Action

Dexmedetomidine acts by activation of α 2 adrenoceptors located in the

presynaptic terminal and inhibits the release of norepinephrine. Activation of α 2
adrenoceptors in the post synaptic terminal in the CNS inhibits sympathetic activity
and can cause sedation, anxiolysis, decreases shivering along with reduced heart
rate and blood pressure. α 2 receptors inhibit adenyl cyclase activity and result in
decreased intracellular cyclic adenosine monophosphate (cAMP) levels. This
inhibition of adenyl cyclase activity is transduced by the inhibitory regulatory protein
Gi. The α2 agonists’ actions are readily reversed by α 2 adrenergic antagonists
(e.g.atipemazole).30

ANALGESIA

Dexmedetomidine has complex analgesic effects. There are two

predominant mechanisms to achieve analgesia namely, activation of descending
spinal inhibition and direct activation of presynaptic α2receptors on sensory afferent
terminals in the dorsal horn. Analgesic effects are principally mediated through α 2
receptors when the drug is injected via intrathecal or epidural route.31

EFFECTS ON THE CENTRAL NERVOUS SYSTEM

It causes anxiolysis, analgesia, arousable sedation dose dependant

amnesia, preserves cerebral oxygen supply demand ratio, reduces cerebral blood
flow and reduces cerebral metabolic rate.

EFFECTS ON RESPIRATORY SYSTEM

It causes decrease in minute ventilation, but the ventilator responses of CO2

are retained.32 Higher concentrations produce a 20 % increase in PaCO2.

EFFECTS ON CARDIOVASCULAR SYSTEM

α2 agonists are characterized by decreased heart rate, systemic vascular

resistance and decreased systemic blood pressure.

15
USES

(i) INTENSIVE CARE UNIT

Dexmedetomidine is used for sedation in mechanically ventilated patients

and lesser amounts of opioids are required when dexmedetomidine is used instead
of benzodiazepines. It produces unique characteristics of sedation with minimal
respiratory depression. When dexmedetomidine used for sedation provides a more
stable hemodynamics during weaning.33

ii) ANAESTHESIA

Dexmedetomidine has been used as a premedication in doses of

0.3 - 0.6μg/kg, reducing the requirements of intravenous and volatile anaesthetics
and also attenuating the hemodynamic stress response to endotracheal
intubation.34,35 Dexmedetomidine is also used for sedation in patients for monitored
anaesthesia care.

(ii) ANTISHIVERING AGENT

The anti-shivering effects of α2 adrenoceptor agonists are mediated by

binding to α2 receptors that mediate vasoconstriction and shivering. In addition to
this, it has hypothalamic thermoregulatory effects.36 Dexmedetomidine reduces the
vasoconstriction and shivering thresholds. It prevents shivering by acting on the
central thermoregulatory system rather than preventing shivering peripherally.

TRAMADOL

Tramadol is a synthetic, centrally acting analgesic agent which is structurally

related to codeine and morphine. It is a racemic mixture of 2 enantiomers, which
enhance analgesic actions. It was first synthesised by Grunenthal in 1962.

16
 Figure 7: Chemical Structure of tramadol

Mechanism of action

Tramadol act synergistically on descending inhibitory pathway in the CNS,

resulting in the modulation of second order neurons in the spinal cord. These
inhibitory pathways mediated by the raphe nuclei, periaqueductal grey, locus
coeruleus and reticulospinal projections involve both opioid and monoamine
neurotransmitters.

Tramadol unique dual mechanism of action like weak opioid agonist. It

stimulates µ receptor and weak norepinephrine and serotonin reuptake inhibitor
synergistic actions enhance its analgesic effects. It activates spinal inhibition of pain
by decreasing the reuptake of norepinephrine and serotonin Tramadol is one fifth
to one tenth as potent as morphine.

PHARMACO KINECTIS

It is available in various forms

1) Solutions for IV, IM, SC administration

2) Formulations for oral like capsules, tablets or drops. Sustained release

formulations are also available.

3) Suppositories for per rectal administration

17
4) Preservative free forms are used in epidural blocks and neuromuscular
blocks.

Distribution

Oral bioavailability is 75%. Peak plasma concentration occurs at 2 hours. Vd

is 2.6 l/kg. Plasma protein binding is approximately 20%. Tramadol is extensively
metabolized by CYP2D6 and CYP 3A4. 30% is excreted in urine as unchanged
drug. The major metabolic pathway is N and O demethylation and glucuronidation.
O desmethltramadol marked as M1 is a pharmacologically active metabolite.
Tramadol is eliminated primarily by liver and metabolites by kidney. The half-life of
tramadol is 6 hours and M1 is 7 hours.

Metabolism and Elimination

Tramadol undergoes extensive first pass metabolism in the liver via two
main metabolic pathways CYP3A and CYP2 D6, only one metabolite is active.
About 10-30% eliminated in urine as unmetabolised form. It is excreted via kidneys
90% and 10% via feces.

Renal & Hepatic Diseases

Since tramadol is eliminated renally, its elimination is relatively prolonged in

hepatic and renal disorders. In patients with advanced cirrhosis its elimination half
life is extended.

Drug Interaction

Tramadol is metabolized by CYP3A and CYP2D6 enzymes. Drugs acting on

these enzymes, should be used with utmost care. It includes, cimetidine, quinidine,
fluoxetine, carbamazepine, amitriptyline etc. MAOI inhibitiors and other drugs that
lower seizure thresholds are used cautiously with tramadol.

18
PHARMACO DYNAMICS

Respiratory system

It produce dose dependent respiratory depression, which is mediated by a

decrease in the sensitivity of respiratory centre to CO2 which results in decreased
respiratory rate and tidal volume.

Cardiovascular system

It does not have effects on heart rate, blood pressure, mean pulmonary
artery pressure, pulmonary capillary wedge pressure, stroke volume index and total
peripheral resistance.

Gastrointestinal system

It causes minimal effect on gastro intestinal function when compared to other

opiods. It causes minimal increase in gastric emptying and colonic transit time. Side
effects are nausea, vomiting and altered appetite.

Central nervous system

It produces sedation, headache, dizziness, euphoria, dysphoria and

seizures. Incidence of seizures is less than 1%. Hence cautiously used in epileptic,
alcohol and drug withdrawal patients and those on anti depressant therapy. It has
anti-convulsant property mediated by kappa receptors. It also has antidepressant
effect due to monoaminergic uptake inhibition.

Analgesic effects

The analgesic effect is due to synergistic activity of its racemic with

metabolite O-desmethyl tramadol. The peak effect occurs 1 to 4 hrs after oral
administration. Duration persists for 3 to 6 hrs after onset.

Overdose

It can produce significant neurotoxicity like seizures, coma, respiratory

failure, tachycardia and hypertension on over dosage. The most common overdose

19
symptoms are lethargy (30%), nausea (14%) agitation (10%), seizures (8%), coma
(5%), hypertension (5%), respiratory depression 2%. No serious cardiotoxicity
noted on overdose.

Uses

1. It is used in the treatment of acute pain

2. It is used in patients with low pulmonary reserve like elderly, obese and
preexisting cardiopulmonary diseases.

3. Pain relief for surgical procedures of thorax and upper abdomen

4. In patient control analgesia in surgical procedures including abdominal,

orthopedic and cardiac surgery.

5. In day care surgery

6. Used in acute orthopaedic trauma and sports injuries.

7. Used in patients with colicky abdominal pain and acute appendicitis

8. It is found to be effective in obstetric analgesia.

9. Tramadol improves gastro intestinal recovery from abdominal surgery.

10. It is beneficial in whom NSAIDS are contra-indicated like patients with peptic
ulcers.

11. It is cautiously used in patients with impaired renal, hepatic or cardiac

function.

20
CLONIDINE
Clonidine is a centrally acting selective partial alpha-2 agonist (220:1 alpha-
2 to alpha-1)

Chemical structure

N-(2,6- dichlorophenyl)-4,5-dihydro -1 H -imidazol-2-amine

Fig: 8 Chemical Structure of Clonidine

21
MECHANISM OF ACTION

Alpha-2 adrenergic agonists produce clinical effects by binding to alpha-2

receptors which are of three subtypes: alpha-2a, alpha-2b, alpha-2c.37

● Alpha-2a receptors mediate sedation, analgesia and sympatholysis.

● Alpha-2b receptors mediate vasoconstriction and possibly the antishivering

effects.

● Alpha-2c receptors-The startle response may reflect activation of these

receptors.

1) Clonidine stimulates alpha-2a adrenergic inhibitory neurons in the medullary

vasomotor center. As a result, there is a decrease in sympathetic nervous
system outflow from CNS to peripheral tissues. Decreased sympathetic nervous
system activity is manifested as peripheral vasodilation and decrease in
systemic blood pressure, heart rate and cardiac output.38

2) The ability of clonidine to modify the function of potassium channels in the CNS
(cell membranes become hyperpolarized) may be the mechanism for profound
decreases in anaesthetic requirements produced by clonidine. Drugs acting on
alpha-2 receptors produce sedation by decreasing sympathetic nervous system
activity and the level of arousal.39

3) Neuraxial placement of clonidine inhibits spinal substance P release and

nociceptive neuron firing produced by noxious stimuli. Activation of post synaptic
α receptors in the substantia gelatinosa of the spinal cord is the presumed
mechanism by which clonidine produces analgesia.40

22
PHARMACOKINETICS

 Metabolism

50% of the drug gets metabolized in the liver. Rest is excreted unchanged
by the kidneys.

 Distribution

Being lipid soluble, clonidine crosses placenta and enters breast milk. It
should therefore be used cautiously in pregnant and lactating females.

 Excretion

Kidney is the main route of excretion.

PHARMACODYNAMICS

Cardiovascular Effects:

Clonidine decreases systolic and diastolic blood pressure. In patients treated

chronically, systemic vascular resistance is little affected and cardiac output which
is initially decreased, returns toward predrug levels. Homeostatic cardiovascular
reflexes are maintained.

Renal Effects:

Renal blood flow and glomerular filtration rate are maintained.

Respiratory Effects:

Alpha- agonists have minimal depressant effects on ventilation and these

agonists do not potentiate ventilator depressant effects of opioids.

23
CNS Effects:

Clonidine produces sedation by decreasing sympathetic nervous system

activity and the level of arousal. There is a profound decrease in anaesthetic
requirements produced by clonidine.

DOSAGE AND ADMINISTRATION

Clonidine is available in following formulations:

1) Oral Tablets-100 µg OD or BD, max 300 µg TDS.

2) Transdermal Patch-A transdermal formulation CLONIDINE-TTS delivering

0.1, 0.2 or 0.3 mg daily for a week is available. It avoids fluctuations in
clonidine blood levels and has a lower incidence of side effects.

3) Intravenous Injection- IV preparation is available as 150 ug/ml. Dose is

1-2µg/kg.

SIDE EFFECTS

1. Sedation, mental depression, disturbed sleep

2. Dryness of mouth, nose, eyes

3. Bradycardia

4. Retention of sodium and water

5. Skin rashes are frequent

6. Impotence occurs occasionally

7. Orthostatic hypotension is rare.

8. Withdrawal syndrome - Alarming rise in blood pressure, tachycardia,

restlessness, anxiety, sweating, headache, nausea and vomiting occur in

24
 some patients when doses of clonidine are missed for 1-2 days, specially in
patients taking > 300 µg/day.

USES:

1. Antihypertensive Drug:

Clonidine acts as an antihypertensive drug by virtue of its ability to decrease

sympathetic nervous system output from the CNS. It is effective in treatment of
patients with severe hypertension or renin dependent disease. The usual daily adult
dose is 0.2 to 0.3 mg orally.

2. Preanaesthetic Medication:

Oral clonidine when used as preanaesthetic medication blunts reflex

tachycardia associated with direct laryngoscopy for intubation of the trachea,
decreases blood pressure and heart rate, decreases the plasma catecholamine
concentrations, dramatically decreases anaesthetic requirements for inhaled (MAC)
and injected drugs and enhances the postoperative analgesia provided by
intrathecal morphine plus tetracaine without increasing the intensity of the side
effects from morphine.41

3. Analgesia:

Preservative-free clonidine administered into the epidural or subarachnoid

space (150 to 450 µg) produces dose dependent analgesia.

4. Prolonging the effects of Regional Anaesthesia:

Intrathecal clonidine prolongs the duration of sensory and motor blockade

produced by the local anaesthetic. Oral clonidine, 150 to 200µg administered 1.0 to
1.5 hours before institution of spinal anaesthesia with tetracaine results in a
significant prolongation of sensory anaesthesia.42

25
5. Protection Against Perioperative Myocardial Ischaemia:

Clonidine 0.2 mg orally or as transdermal patch administered the evening

before surgery or on the morning of surgery to patients at risk for coronary artery
disease and continued for 4 days post operatively decreased the incidence of
perioperative myocardial ischaemia with minimal haemodynamic effects.

6. Diagnosis of Phaeochromocytoma:

Clonidine 0.3 mg orally, will decrease the plasma concentration of

catecholamines in normal patients but not in the presence of phaeochromocytoma.

TREATMENT OF OPIOID AND ALCOHOL WITHDRAWAL SYNDROME

Clonidine 10µg/kg i.v. decreases sympathetic nervous system activity that is

associated with cardiovascular stimulation and attenuates increases in plasma
catecholamine concentrations during general anaesthesia to patients addicted to
opioids.

7. Treatment of Shivering:

Clonidine exerts its anti-shivering effects at three levels: Hypothalamus,

locus coeruleus and spinal cord. At the hypothalamic level, it decreases
thermoregulatory threshold for vasoconstriction and shivering, because
hypothalamus has high density of α2 adenoceptors and hence is effective in treating
the established post-anaesthetic shivering.43,44 It also reduces spontaneous firing
in locus coeruleus - a pro-shivering centre in pons.45 At the spinal cord level, it
activates the α2 adrenoreceptors and release of dynorphine, norepinephrine and
acetylcholine.46 The depressor effects of these neurotransmitters at the dorsal horn
modulate cutaneous thermal inputs.47 Clonidine is highly lipid-soluble and easily
crosses the blood-brain barrier.48 Due to these merits, interaction at the α2
adrenoreceptors at spinal and supraspinal sites occurs within the central nervous
system.49

26
 REVIEW OF LITERATURE

Shivering is a common post anaesthetic occurrence which is defined as

involuntary repetitive activity of skeletal muscle. It is a common and distressing
experience to many patients which occur either during or immediately after the
surgery. The incidence of shivering following spinal anaesthesia is 30-60%. Spinal
anaesthesia is widely used as safe anaesthesia technique for both elective and
emergency operations including all open gynaecology and obstetric surgery,
orthopedic and plastic surgery of lower limb and pelvis, general surgery of pelvis
and lower abdomen and majority of urological procedure.2

The main causes of intra operative or post operative shivering are heat loss,
increased sympathetic tone, pain and systemic release of pyrogens. Shivering is
potentially serious complication that occurs in 20-70% of the surgeries in post
operative period. The shivering can increases metabolic rate, increased oxygen
consumption (upto 100-600%) and with increased carbon dioxide production,
increased ventilation and increased cardiac output. It causes arterial hypoxemia,
lactic acidosis, increased intraocular pressure and intracranial pressure. Shivering
itself interferes with pulse rate, blood pressure and electrocardiography monitoring.3

It is a physiological response to core heat production. The core body

temperature is maintained within range of 36.5-37.5o C which is known as thermo-
neutral zone. Thermo regulatory response like vasoconstriction and shivering are
activated when core body temperature falls below normal range. 4 The spinal α
motor neurons and their axons mediate the neurological mechanism of shivering
with centre at pre-optic nucleus of the anterior hypothalamus.5

After spinal anaesthesia shivering is more common than after general

anaesthesia as vasoconstriction effect after heat loss during surgery is lost when
patient in under spinal anaesthesia due to sympathetic blockade.

27
 Shivering is due to inhibition of thermo-regulation and non thermo-regulatory
mechanism, pain, uncontrolled spinal reflexes and cutaneous vasodilation.

There are many non pharmacological and pharmacological methods to

control shivering. The non pharmacological methods include use of warm blankets,
warm iv fluids, use of external warmer, warming of skin surface.

Delaunay et al (1993) showed that clonidine reduced the thermoregulatory

threshold for vasoconstriction. It acts by impairing central thermoregulatory control.
Clonidine significantly decreased the thermoregulatory threshold for shivering by
0.6 ± 0.3°C. Similarly, the threshold for cutaneous vasoconstriction was significantly
reduced by 0.5 ± 0.2°C. Additional clonidine administration always stopped
shivering, at whatever temperature it occurred. That an additional dose of clonidine
stops shivering in subjects already given one dose, indicates that the effect of
clonidine is dose dependent.50

Chan and co-workers in 1999 investigated the dosage of tramadol which was
effective in controlling shivering under regional anesthesia in obstetric patients in
randomized double blinded study on 36 patients, 12 were allocated to 0.5mg/kg
tramadol group, 13 were allocated to 0.25 mg/kg tramadol group and 11 were
allocated to 0.05 ml/kg normal saline group. Shivering was controlled in 80%
patients in 0.5 mg/kg tramadol group, 92% patients in 0.25% mg/kg tramadol group,
and 27% in normal saline group. They concluded that intravenous tramadol
controlled shivering in obstetric patients and no demonstrable difference in
response rate or incidence of side effects between the two doses 0.5mg /kg and
0.25mg/kg.51

Tasai YC et al (2001) conducted a study in which both tramadol (0.5mg/kg)

and meperidine (0.5mg/kg) effectively treated patients with post epidural
anaesthetic shivering. However, amitriptyline at both 15 and 20mg did not show
significant effects in the treatment of shivering.52

Mohta M et al (2009) concluded that the efficacy of intravenous tramadol in

the doses of 1, 2 and 3mg/kg is comparable to that of intravenous pethidine

28
0.5mg/kg to prevent postanaesthetic shivering. Tramadol 2mg/kg appears to be a
good choice to be administered at the time of wound closure to provide the dual
advantage of antishivering effect as well as analgesia without significant side effects
in the postoperative period.53

Bansal P et al (2011) conducted a study that butorphanol and tramadol were

more effective than clonidine in suppressing shivering. Butorphanol, tramadol, and
clonidine completely controlled rigors in 83%, 73%, and 53% of cases, respectively,
and incompletely suppressed rigors in 16%, 26%, and 46% of cases, respectively.
Time taken to terminate rigors was significantly higher for clonidine (3.3 ± 0.9
minutes) than for butorphanol and tramadol (2.1 ± 1.0 minutes and 1.8 ± 0.5
minutes). Butorphanol had an edge over tramadol in controlling shivering with lower
chances of recurrence, though both were superior to clonidine for this purpose with
an early onset of action. They conclude that both these opioids control rigors better
than α-2 agonists.54

Shukla et al (2011) observed that both clonidine (0.5μg/kg) and tramadol

(0.5mg/kg) effectively treated patients with post–spinal anaesthesia shivering, but
tramadol took longer time to achieve complete cessation of shivering than clonidine,
the difference being statistically significant. So they concluded that clonidine offers
better thermodynamics than tramadol, with fewer side effects. The more frequent
incidence of side effects of tramadol, like nausea, vomiting and dizziness, may limit
it's use as an anti-shivering drug.55

Reddy VS et al in (2011) conducted a study to compare tramadol and

clonidine showed that time taken from the starting of treatment to cessation of
shivering was significantly less with the tramadol group, however, the frequency of
nausea, vomiting, sedation and headache were also significantly more in the
tramadol group. They concluded that both clonidine and tramadol control shivering.
However, the response rate was higher and time taken to control shivering was
lesser with tramadol, but the response rate and the side effects were lesser with
clonidine.56

29
 Usta et al (2011) conducted a study on dexmedetomidine infusion for the
prevention of shivering during spinal anesthesia. They reported that
dexmedetomidine infusion of 0.4µg/kg/h was effective in preventing shivering and
providing sedation for minor surgical procedure. The sedation achieved was better
in dexmedetomidine than clonidine and tramadol.57

Yousuf B, et al in 2013 evaluated the efficacy of tramadol in preventing post-

operative shivering using thiopentone and propofol as induction agent in general
anaesthesia. It was a randomized controlled trial, 124 patients under going general
anaesthesia for various procedures who received either thiopentone or propofol as
induction agent. Each group subdivided to receive either tramadol or saline before
wound closure. They observed higher incidence of post operative shivering in
thiopentone group and lowest in propofol group (p<0.05). They concluded that
prophylactic use of tramadol in a dose of 1mg/kg with propofol as an induction
agent, significantly reduced the incidence of post operative shivering in patients
recovering from general anaesthesia.58

Bozgeyik et al (2014) performed a study to see the effect of preemptive

tramadol and dexmedetomidine in shivering during arthroscopy. They observed that
in addition to its effectiveness in preventing shivering, dexmedetomidine was
superior in increasing level of sedation to prevent sedation without side effects.59

Mital et al in (2014) performed a study for comparision of dexmedetomidine

and tramadol for post spinal anesthesia shivering. They concluded that
dexmedetomidine in a dose of 0.5µg/kg has faster onset to control shivering in
2.5±0.44min.60

Singla A et al 2017 conducted a study on efficacy and safety of tramadol and

dexmedetomidine in treatment of shivering following spinal anaesthesia
(randomised controlled study). They concluded that patient received
dexmedetomidine has more cases of bradycardia as compared to tramadol
(p>0.05). However difference these group was statistically non significant.61

30
 A study done by Panneer M et al (2017) showed that dexmedetomidine 0.5
μg/kg is more effective than clonidine 1 μg/kg in controlling postspinal blockade
shivering. Dexmedetomidine has early onset of effect, high response rate, and less
recurrence rate with added advantage of good sedation and stable
cardiorespiratory parameters.62

Kundra TS et al (2017) conducted a study on the patients who received

dexmedetomidine as well as tramadol had cessation of shivering. The time to
cessation of shivering was significantly less with dexmedetomidine (174.12 ±
14.366 seconds) than with tramadol (277.06 ± 23.374 seconds). The recurrence
rate of shivering with dexmedetomidine was less (6%) as compared to tramadol
(16%). Nausea and vomiting was found to be higher in the case of tramadol. On the
other hand, dexmedetomidine caused moderate sedation from which the patient
could be easily woken up. They observed that dexmedetomidine offers better
results than tramadol with fewer side effects.63

Verma A et al (2018) conducted a study and showed that in 98.48% of

patients shivering ceased after administration of dexmedetomidine, whereas
success rate was 86.67% in tramadol group. There was early response as well as
less recurrence of shivering in dexmedetomidine group. Nausea and vomiting
occurred significantly more in tramadol group. There was no significant
haemodynamic instability in any group. Dexmedetomidine when used at a dose of
0.5 µg/kg IV is more effective and rapid than tramadol used at a dose of 0.5 mg/kg
IV to treat shivering as developed after spinal anaesthesia without any increased
side effects as well as inducing a comfortable sedation for the patient. 64

Venkatraman R et al (2018) conducted a study on dexmedetomidine and

observed to be faster in the control of shivering in 5.7 ± 0.79 minutes (min) whereas
tramadol took 6.76 ± 0.93 min and clonidine was slower with 9.43 ± 0.93 min. The
recurrence rate was much lower in the dexmedetomidine group with 3.3% than for
clonidine (10%) and tramadol (23.3%) group. The sedation achieved with
dexmedetomidine was better than clonidine and tramadol. The tramadol group had
more cases of vomiting (four) and dexmedetomidine group had six cases of

31
hypotension and two cases of bradycardia. Two of the clonidine patients
encountered bradycardia and hypotension. However dexmedetomidine is better
than tramadol and clonidine in the control of shivering because of its faster onset
and less recurrence rate. Though complications are encountered in the
dexmedetomidine group but they are treatable.65

Wang J (2020) conducted a randomized controlled trial including 864

subjects. Dexmedetomidine had higher effective rate of shivering control (RR =1.03;
95%CI [1.01, 1.06], P = 0.01, I2 = 14%), shorter time to cease shivering (MD = -
2.14; 95%CI [− 2.79, − 1.49], P < 0.00001, I2 = 98%), lower recurrent rate of
shivering (RR = 0.45; 95%CI [0.27, 0.73], P = 0.001, I2 = 0%), lower incidences of
nausea (RR = 0.10; 95%CI [0.05, 0.19], P < 0.00001, I2 = 48%), and vomiting (RR
= 0.13; 95%CI [0.06, 0.30], P < 0.00001, I2 = 0%), higher incidence of sedation (RR
= 2.48; 95%CI [1.32, 4.65], P = 0.005, I2 = 82%), hypotension (RR = 2.50; 95%CI
[1.24, 5.03], P = 0.01, I2 = 0%) and bradycardia (RR = 4.78; 95%CI [1.76, 13.00],
P = 0.002, I2 = 0%), compared with tramadol. They concluded that
dexmedetomidine is superior to tramadol for shivering treatment, due to higher
effective rate of shivering control, earlier onset of action and lesser recurrence of
shivering with higher incidence of sedation and lower incidences of nausea and
vomiting. However, dexmedetomidine is also associated with higher incidences of
hypotension and bradycardia than tramadol.66

32
 AIMS AND OBJECTIVES

Primary objective:-

 To study the effect of tramadol, clonidine and dexmedetomidine on post

operative shivering.

Secondary objective:-

 To compare the effect of tramadol, clonidine and dexmedetomidine on

haemodynamics.

 To compare the adverse effect among all three drugs.

33
 MATERIAL AND METHOD

STUDY DESIGN:-

It was prospective randomized double blind study conducted in Guru Nanak

Dev Hospital attached to Government Medical College, Amritsar after taking written
informed consent from patients in their vernacular language and approval from
Institutional Ethics Committee (IEC). This study was conducted on 90 patients,
aged 18-60 years, American Society of Anesthesiologists (ASA) Grade I and II who
were scheduled to undergo elective surgeries under spinal anesthesia and those
who developed shivering were included in the study.

INCLUSION CRITERIA:-

 Patient group age between 18-60 years.

 Patient in ASA Grade I and II.

 Patient undergoing elective surgery under spinal anaesthesia.

EXCLUSION CRITERIA:-

 Patient with known hypersensitivity to clonidine, dexmedetomidine and

tramadol.

 Known history of alcohol or substance abuse.

 Known history of hyperthyroidism, cardiovascular diseases, physiological

disorders, severe diabetes or autonomic neuropathy and urinary tract
infection.

 Patient with ASA III and above, cardiac, liver and renal diseases, allergy to
any of study drug or patient refusal and pregnant patient.

 Patient with coagulopathy, elderly (age >65 years), bradycardia (heart rate
<60/min).

34
STUDY GROUPS:

The patients who developed shivering under spinal anesthesia were

randomly divided into three groups with 30 patients in each group. Group A patients
received tramadol 1 mg/kg intravenously, Group B received clonidine 1
µg/kg intravenously and Group C received dexmedetomidine 0.5 µg/kg
intravenously. The group allotment was decided by the computer generated random
envelope method. The first anesthesiologist opens the envelope and adds the study
drug in a 100 mL normal saline and hands it to the second anesthesiologist who
was blinded to the study drug. He administers the drug over 10 min and monitors
the patient.

PRE-ANAESTHETIC CHECKUP

A detailed PAC was done a day before the surgery. Details pertaining to the
patient’s clinical history, general physical and systemic examinations was taken.
Assessment of patient’s airway was done. Patients were instructed to fast for 6-8
hours for solids and 2 hours for clear fluids before surgery.

INFORMED CONSENT

Informed consent was taken from the patients after explaining technique and
its complications in patient’s vernacular language.

INVESTIGATIONS:-

 Electrocardiogram

 Haemoglobin

 Total Leucocytes Count

 Differential Leucocytes Count

 Bleeding time

 Clotting Time

35
 Renal Function Test

 Liver Function Test

 Viral Markers

MATERIAL REQUIRED:

 Intravenous cannula

 Infusion Set

 Ringer lactate / Normal Saline bottles

 Sponge holding forceps

 Sterile Draping sheet

 Gauze pieces

 Disposable Syringes

 Povidine Iodine Solution

 Sterile gloves

 Spinal Needle 23G

 Inj. Bupivacaine 0.5% hyperbaric 4ml ampoule

TECHNIQUE

On the day of surgery, all the vitals were recorded preoperatively. After
shifting the patient, multiparameter was attached to the patients and continuous
monitoring of pulse rate, blood pressure, respiratory rate, SpO2 and axillary
temperature was done. After venous cannulation, patient were preloaded with
ringer lactate solution. Under all aseptic condition, patient was asked to lie in left
lateral position. Back of the patient was painted with betadine and draped.
Intervertebral space palpated. 23G spinal needle was inserted into L3-L4 space.
0.5 % of 3.2ml heavy bupivacaine was injected into subarachnoid space. Patient

36
was immediately turned to supine position. Oxygenation was started via simple
oxygen mask (5 litres/min). Surgery were allowed to proceed under obtaining
adequate level of anaesthesia.

The operating room temperature were maintained at 22°C for all the
surgeries. No external warming devices was used and fluids were administered at
room temperature to all patients. The patient who developed shivering under spinal
anesthesia were randomly divided into three groups with 30 patients in each group.
Group A patients received tramadol 1 mg/kg intravenously, Group B received
clonidine 1 µg/kg intravenously and Group C received dexmedetomidine 0.5 µg/kg
intravenously.

The shivering intensity was graded on a scale of 1-4 as per Wrench.

Grade 1: Patients having one or more of the following: piloerection, peripheral

vasoconstriction, peripheral cyanosis, but without visible muscle
activity.

Grade 2: Visible muscle activity confined to one muscle group.

Grade 3: Visible muscle activity in more than one muscle group.

Grade 4: Gross muscle activity involving the whole body. The patients were
included in the study when they develop shivering with at least a
Grade of 2.

The hemodynamic monitoring was continued after the administration of

study drugs. The time taken to control shivering, recurrence and adverse effects
like nausea, vomiting, dry mouth and sedation score was observed. The sedation
score proposed by Filos et al was followed.

Grade 1: Awake and alert patient.

Grade 2: Drowsy patient responding to verbal stimuli.

Grade 3: Drowsy but arousable to physical stimuli and

Grade 4: Unarousable patient.

37
 The monitoring was continued for two hours after the administration of spinal
anesthesia.

STATISTICAL ANALYSIS:-

After taking consultation with statisticians and monitoring parameters of the

study i.e. blood pressure, oxygen saturation, respiratory rate, pulse rate, adverse
effects of the study drugs etc. and to make the power of the study more than 85%.
This study was conducted in 90 patients who were randomly divided into three
groups with 30 patients in each groups. The data from the present study was
systematically collected, compiled and statistically analysed to draw relevant
conclusion.

Continuous data was presented as mean with standard deviation.

Categorical data was expressed as percentages. Numerical variables were
normally distributed and were compared using Chi Square test for non-parametric
data and POSTHOC ANOVA test for parametric data. The p value was then
determined to evaluate the level of significance.

Sample size was calculated keeping in view at most 5% risk, with minimum
85% power and 5% significance level (significant at 95% confidence interval). Data
was recorded in a Microsoft excel spread sheet and analysed using Statistical
Package for the IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM
Corp., Chicago

The results were analysed and compared to previous studies to draw

relevant conclusions.

38
 OBSERVATIONS AND RESULTS

TABLE 1
AGE GROUP IN YEARS

AGE Group A Group B Group C

GROUP IN
YEARS No. %age No. %age No. %age

18-20 1 3.33 1 3.33 3 10.00

21-30 4 13.33 9 30.00 7 23.33
31-40 11 36.67 5 16.67 8 26.67
41-50 10 33.33 11 36.67 10 33.33
51-60 4 13.33 4 13.33 2 6.67
Total 30 100.00 30 100.00 30 100.00

12

10

8
No. of cases

0
<20 21-30 31-40 41-50 51-60
AGE GROUP (YEARS)

Group A Group B Group C

39
 TABLE 2
MEAN AGE

Group A Group B Group C

Mean age (in years) 40.03 38.86 39.46

Standard Deviation(SD) 10.29 12.22 9.12

p- value A/B 0.821 (NS)

B/C 0.761 (NS)
A/C 0.711 (NS)

45
40
35
30
Mean age

25
20
15
10
5
0
Group A Group B Group C

This table shows age group distribution in three groups.

Group A (30) comprises of 1patient in 18-20 years (3.33%), 4patients in 21-

30 years (13.33%), 11 patients in 31 – 40 years (36.67%), 10 patients in 41 – 50
years (33.33%), 4 patients in 51 – 60 years (13.33%) of age group.

Group B (30) comprises of 1 patient in less than 20 years (3.33%), 9 patient

in 21 – 30 years (30%), 5 patients in 31 – 40 years (16.67%), 11 patients in 41-50
years (36.67%), 4 patients in 51 – 60 years (13.33%).

40
 Group C (30) Comprises of 3 patients in less than 20 years (10%), 7 patients
in 21 – 30 years (23.33%), 8 patients in 31 – 40 years (26.67%), 10 patient in 41 -
50 patients (33.33%), 2 patients in 51 - 60 years (6.67%).

The patient in all the three groups were found to be comparable with respect
to age distribution. The difference in mean age of three groups was found to be
statistically nonsignificant. (p-value A/B is 0.821, B/C 0.761, A/C 0.711.

41
 TABLE 3
SEX

Sex Group A Group B Group C

No. %age No. %age No. %age

Female 14 46.67 16 53.33 11 36.67
Male 16 53.33 14 46.67 19 63.33
Total 30 100.00 30 100.00 30 100.00
X2:1.702; p=0.426

20
18
16
14
No. of cases

12
10
8
6
4
2
0
Female Male
SEX

Group A Group B Group C

The above table shows gender based correlation between three groups.
There were 14 females (46.67%) and 16 males (53.33%) in group A, 16 females
(53.33%) and 14 males (46.67%) in group B and 11 females (36.67%) and 19 males
(63.33%) in group C. However no significant difference was seen between three
groups (p value =0.426).

42
 TABLE 4
ASA GRADE

ASA Group A Group B Group C p- value

Grade
No. %age No. %age No. %age A/B B/C A/C

I 21 70.00 21 70.00 24 80.00

1.00 0.371 0.371
II 9 30.00 9 30.00 6 20.00
(NS) (NS) (NS)
Total 30 100.00 30 100.00 30 100.00

25

20
No. of cases

15

10

0
I II
ASA GRADE

Group A Group B Group C

The above table shows number of patients in ASA grade I and II were 21
(70%) and 9 (30%) in group A, 21 (70%) & 9 (30%) in group B, 24 (80%) and 6
(20%) in group C respectively. Hence, patients in the three groups were comparable
with respect to ASA grade distribution and difference was statistically non significant
(p value A/B 1.0, B/C is 0.371 and A/C is 0.371.)

43
 TABLE 5
DISTRIBUTION ACCORDING TO SURGICAL PROCEDURE PERFORMED

Operative procedure Group A Group B Group C

No. %age No. %age No. %age

Cesarean Section 4 13.33 4 13.33 6 20.00
External fixator 2 6.67 2 6.67 2 6.67
Fistulectomy 0 0.00 0 0.00 1 3.33
Haemorrhoidectomy 2 6.67 2 6.67 2 6.67
Hernioplasty 5 16.67 6 20.00 5 16.67
ILN Tibia 3 10.00 1 3.33 1 3.33
Jaboulys repair 2 6.67 4 13.33 2 6.67
Others 11 36.67 10 33.33 9 30.00
Pilonidal Sinus Excision 1 3.33 1 3.33 1 3.33
Stripping and Ligation 0 0.00 0 0.00 1 3.33
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B X2: 1.805; p=0.970
Group B v/s C X2: 3.210; p=0.955
Group A v/s C X2: 3.600; p=0.936

12

10
No. of cases

OPERATIVE PROCEDURE

Group A Group B Group C

The above table shows that no. of patients under each type of surgical
procedure was comparable in the groups. The difference between the groups was
statistically non significant (p value >0.05). Hence patient in groups were
comparable with respect to the type of surgery.

44
 TABLE 6
TIME OF ONSET OF SHIVERING (MINUTES)

Time of Onset of Group A Group B Group C

Shivering (minutes)
Mean SD Mean SD Mean SD
Mean time of onset of
23.2 6.38 24.66 7.12 25.2 6.96
shivering
p-value: Group A v/s B 0.425
Group B v/s C 0.742
Group A v/s C 0.250

25.5

25

24.5
No. of cases

24

23.5

23

22.5

22
Mean time of onset of Shivering
SHIVERING

Group A Group B Group C

The above table shows mean time for onset of shivering in Group A
23.2±6.38 minutes, Group B 24.66±7.12 and Group C 25.2±6.96 minutes. The
difference between the groups was statistically non-significant (p>0.05).

45
 TABLE 7
SHIVERING CONTROL

Shivering control Group A Group B Group C

No. %age No. %age No. %age

Complete 30 100.00 22 73.33 27 90.00
Incomplete 0 0.00 8 26.67 3 10.00
p-value: Group A v/s B 2
X : 9.231; p=0.002
Group B v/s C X2: 2.783; p=0.095
Group A v/s C X2: 3.158; p=0.075

30

25

20
No. of cases

15

10

0
YES NO
SHIVERING

Group A Group B Group C

The above table shows control of shivering in all the three groups. Group A
had 30 patients (100%) complete control, in group B 22 (73.33%) patients had
complete control and 8 (26.67%) patients had incomplete control. Whereas in group
C 27 (90%) patients had complete control and only 3 (10%) patients had incomplete
control. The difference between group A v/s B was highly significant, but the
difference between group B v/s C and group A v/s C was statistically non significant.

46
 TABLE 8
TIME TAKEN BY THE DRUG TO CONTROL OF SHIVERING (IN
MINUTES)

Group A Group B Group C

Mean time taken drug administer 5.20 6.14 2.8

to control of shivering (in (300 sec) (360 sec) (116 sec)
minutes)

Standard Deviation (SD) 0.34 0.41 0.12

p- value A/B 0.001 (HS)

B/C 0.001 (HS)
A/C 0.001 (HS)

5
Mean time taken

0
Group A Group B Group C

The above table shows that mean time taken by drug to control of shivering
group C take least time (2.8±0.12 min), group A take (5.2±0.34 min) whereas group
B take more time i.e. (6.14±0.41). The difference between group A and B, group B
and C, group A and C is statistically highly significant (p value <0.001).

47
 TABLE 9
SEDATION SCORE (FILOS)

Sedation score Group A Group B Group C

No. %age No. %age No. %age

1-Awake 14 46.66 7 23.33 4 13.33
2-Drowsy, respond to
14 46.66 17 56.67 20 66.67
verbal stimulus
3-Drowsy, arousable to
2 6.68 6 20.00 6 20.00
physical stimulus
4-Not arousable 0 0.00 0 0.00 0 0.00
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B 2
X : 4.624; p=0.099
Group B v/s C X2: 1.061; p=0.588
Group A v/s C X2: 8.614; p=0.013

20
18
16
14
No. of cases

12
10
8
6
4
2
0
1 Awake 2 Drowsy, respond 3 Drowsy, arousable 4 Not arousable
to verbal stimulus to stimulus
SEDATION SCORE

Group A Group B Group C

The above table shows that sedation score was compared between group
A, group B and group C. The difference between group A and group C is statistically
significant but difference between group A and group B, group B and group C was
found statistically non significant.

48
 TABLE 10
POSTOPERATIVE COMPLICATIONS

Nausea and Vomiting Group A Group B Group C

No. %age No. %age No. %age

Yes 10 33.33 1 3.33 1 3.33
No 20 66.67 29 96.67 29 96.67
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B X2: 9.017; p=0.001
Group B v/s C X2: 0.000; p=1.000
Group A v/s C X2: 9.017; p=0.001

30

25

20
No. of cases

15

10

0
YES NO
NAUSEA AND VOMITING

Group A Group B Group C

The above table shows that nausea and vomiting was observed in all three
groups group, Group A had 10 patients (33.33%), group B had 1 patients (3.33%)
and group C had 1 patients (3.33%). The difference between group A and B, Group
A and C is statistically highly significant but difference between group B and C was
formed statistically non significant.

49
 TABLE 11
BRADYCARDIA

Bradycardia Group A Group B Group C

No. %age No. %age No. %age

Yes 2 6.67 3 10.00 6 20.00
No 28 93.33 27 90.00 24 80.00
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B 2
X : 0.218; p=0.640
Group B v/s C X2: 1.176; p=0.278
Group A v/s C X2: 2.308; p=0.128

30

25

20
No. of cases

15

10

0
YES NO
BRADYCARDIA

Group A Group B Group C

The above table shows that bradycardia was observed in 6 patients (20%)
group C, 3 patients (10%) in group B and 2 patients (6.657%) group A. Hence
difference between these groups was statistically non significant (p >0.05).

50
 TABLE 12
HYPOTENSION

Hypotension Group A Group B Group C

No. %age No. %age No. %age

Yes 5 16.67 8 26.67 11 36.67
No 25 83.33 22 73.33 19 63.33
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B 2
X : 0.884; p=0.347
Group B v/s C X2: 0.693; p=0.405
Group A v/s C X2: 3.068; p=0.079

25

20
No. of cases

15

10

0
YES NO
HYPOTENSION

Group A Group B Group C

The above table shows that hypotension was observed in 11 patients

(36.67%) group C, 8 patients (26.67%) in group B and 5 patients (16.67) in group
A. Hence difference between these groups was statistically non significant (p value
>0.05).

51
 TABLE 13
RECURRENCE OF SHIVERING

Recurrence of Group A Group B Group C

shivering
No. %age No. %age No. %age
Yes 7 23.33 3 10.00 2 6.67
No 23 76.67 27 90.00 28 93.33
Total 30 100.00 30 100.00 30 100.00
p-value: Group A v/s B X2: 1.92; p=0.165
Group B v/s C X2: 0.218; p=0.640
Group A v/s C X2: 3.268; p=0.070

30

25

20
No. of cases

15

10

0
YES NO
RECURRENCE OF SHIVERING

Group A Group B Group C

The above table shows the recurrence of shivering was observed in 7

patients (23.33%) group A, 3 patients (10.00%) group B and 2 patients (6.67%)
group C. Hence difference between these groups was statistically non significant
(p value >0.005).

52
 TABLE 14
HEART RATE (HR)
Time Group A Group B Group C f-value p-value Remarks
interval
Mean SD Mean SD Mean SD A/B B/C A/C
Baseline 79.33 6.22 81.57 9.06 81.60 6.29 -1.59 0.14 0.49 0.08 NS
2 min 76.07 6.37 73.43 8.97 73.47 8.88 1.65 0.10 0.49 0.10 NS
4 min 77.53 6.04 75.07 9.30 78.40 7.95 1.65 0.11 0.07 0.32 NS
6 min 83.17 6.60 81.10 9.80 84.37 9.73 0.79 0.17 0.10 0.29 NS
8 min 81.30 7.70 81.80 10.94 84.07 6.18 -0.24 0.42 0.16 0.07 NS
10 min 82.27 6.48 82.37 10.17 81.37 10.17 -0.06 0.48 0.35 0.34 NS
15 min 86.63 6.38 83.43 12.15 82.87 12.00 1.27 0.10 0.43 0.07 NS
20 min 86.17 6.49 84.80 10.94 86.63 10.88 0.77 0.28 0.34 0.14 NS
25 min 90.12 5.79 89.10 10.17 89.12 10.10 0.11 0.47 0.32 0.25 NS
30 min 86.60 6.69 87.60 9.81 80.90 7.68 -0.04 0.49 0.17 0.11 NS
45 min 82.77 6.17 83.00 10.18 84.63 5.35 -0.16 0.46 0.22 0.11 NS
60 min 82.37 7.05 84.77 6.42 82.83 7.39 -1.60 0.09 0.14 0.40 NS
75 min 82.93 7.38 85.13 5.82 82.10 11.87 -1.87 0.10 0.11 0.37 NS
90 min 86.43 5.61 83.00 10.18 83.83 8.72 1.68 0.06 0.37 0.09 NS
105 min 82.57 5.55 82.90 9.52 82.43 9.03 -0.22 0.43 0.42 0.47 NS
120 min 84.03 7.87 83.67 8.54 81.40 8.52 0.29 0.43 0.15 0.11 NS
53
 100
90
80
70
Mean heart rate

60
50
40
30
20
10
0

TIME INTERVAL

Group A Group B Group C

The above table shows that mean HR in all the groups, mean HR in group
A, mean HR in group B and mean HR in group C at all time points was found to be
comparable and difference between three groups statistically non significant (p
>0.05).

54
 TABLE 15
SYSTOLIC BLOOD PRESSURE (SBP)
Time Group A Group B Group C f-value p-value Remarks
interval
Mean SD Mean SD Mean SD A/B B/C A/C NS
Baseline 122.60 12.76 120.07 9.52 124.87 13.23 0.91 0.19 0.06 0.25 NS
2 min 122.37 9.79 125.43 7.46 125.10 10.09 -1.16 0.09 0.44 0.15 NS
4 min 123.60 13.20 124.03 5.78 127.70 12.96 0.71 0.43 0.08 0.11 NS
6 min 126.10 11.27 125.30 5.65 127.80 12.06 0.69 0.36 0.15 0.29 NS
8 min 123.20 12.57 124.40 7.56 126.50 6.86 -0.51 0.33 0.13 0.11 NS
10 min 126.10 10.41 125.53 10.45 129.10 11.58 0.25 0.42 0.11 0.15 NS
15 min 121.87 16.52 126.03 9.07 126.87 16.52 -1.14 0.12 0.40 0.12 NS
20 min 124.03 10.82 119.83 14.53 123.77 11.63 1.20 0.10 0.13 0.46 NS
25 min 110.23 8.40 111.63 9.12 110.86 10.68 0.61 0.53 0.76 0.80 NS
30 min 112.16 11.49 111.38 13.18 110.18 9.76 -0.24 0.80 0.69 0.47 NS
45 min 124.07 12.55 123.73 8.58 126.70 10.22 0.15 0.45 0.11 0.19 NS
60 min 126.33 10.49 123.90 7.97 127.73 11.37 1.52 0.16 0.07 0.31 NS
75 min 126.23 11.90 123.90 8.43 127.50 12.33 1.14 0.19 0.10 0.34 NS
90 min 125.30 11.87 122.97 8.56 126.40 11.40 1.02 0.19 0.10 0.36 NS
105 min 124.13 12.77 123.90 9.54 127.70 10.82 0.09 0.47 0.08 0.12 NS
120 min 125.73 4.64 123.90 5.24 127.43 12.03 2.28 0.08 0.07 0.24 NS
55
 140

120

100
Mean SBP

80

60

40

20

TIME INTERVAL

Group A Group B Group C

The above table shows than mean SBP in all the groups, mean SBP in group
A, mean SBP in group B and mean SBP in group C at all time points was found to
be comparable and difference between groups statistically non significant (p >0.05).

56
 TABLE 16
DIASTOLIC BLOOD PRESSURE (DBP)
Time Group A Group B Group C f-value p-value Remarks
interval
Mean SD Mean SD Mean SD A/B B/C A/C NS
Baseline 76.97 9.57 78.47 8.35 76.37 8.66 -0.68 0.26 0.17 0.40 NS
2 min 79.87 7.07 79.80 4.04 77.63 7.25 0.83 0.48 0.08 0.12 NS
4 min 74.17 6.50 76.13 4.30 75.40 6.81 -0.10 0.09 0.31 0.24 NS
6 min 80.00 8.18 80.57 4.47 78.23 8.94 -0.22 0.37 0.10 0.21 NS
8 min 81.53 7.30 79.77 8.31 82.07 4.36 0.91 0.19 0.09 0.37 NS
10 min 76.97 8.61 78.47 7.76 76.23 8.33 -0.84 0.24 0.14 0.37 NS
15 min 77.27 8.28 77.57 9.07 78.63 9.25 0.09 0.45 0.33 0.28 NS
20 min 78.30 9.29 76.87 8.97 78.73 7.25 0.33 0.27 0.23 0.43 NS
25 min 71.48 7.87 70.14 8.18 72.08 7.17 -0.64 0.52 0.33 0.75 NS
30 min 70.43 8.93 72.18 9.18 70.88 8.32 0.74 0.45 0.56 0.84 NS
45 min 79.17 8.20 79.57 6.77 81.30 3.30 -0.24 0.42 0.11 0.10 NS
60 min 78.07 7.98 77.63 8.05 78.63 9.19 0.23 0.42 0.33 0.40 NS
75 min 81.67 5.38 79.33 7.99 79.83 7.91 1.87 0.09 0.40 0.15 NS
90 min 78.33 8.95 78.53 9.50 78.83 8.95 -0.09 0.47 0.45 0.41 NS
105 min 78.57 8.93 78.60 9.32 77.77 8.81 -0.01 0.49 0.36 0.36 NS
120 min 78.60 5.03 78.23 5.49 78.90 9.30 0.34 0.39 0.37 0.44 NS
57
 90
80
70
60
Mean DBP

50
40
30
20
10
0

TIME INTERVAL

Group A Group B Group C

The above table shows than mean DBP in all the groups, mean DBP in group
A, mean DBP in group B and mean DBP in group C at all time points was found to
be comparable and difference between groups statistically non significant (p >0.05).

58
 TABLE 17
SpO2
Time Group A Group B Group C f-value p-value Remarks
interval
Mean SD Mean SD Mean SD A/B B/C A/C
Baseline 99.87 0.43 99.87 0.43 99.93 0.25 1.15 0.50 0.24 0.24 NS
2 min 99.90 0.31 99.93 0.25 99.90 0.31 1.94 0.32 0.32 0.50 NS
4 min 99.87 0.35 99.87 0.35 99.93 0.25 1.74 0.50 0.20 0.20 NS
6 min 99.90 0.31 99.90 0.31 99.97 0.18 -1.15 0.50 0.15 0.15 NS
8 min 99.93 0.25 99.93 0.25 99.90 0.31 -1.15 0.50 0.32 0.32 NS
10 min 99.90 0.40 99.93 0.37 99.93 0.25 -1.15 0.37 0.50 0.35 NS
15 min 99.90 0.31 99.93 0.25 99.90 0.31 0.51 0.32 0.32 0.50 NS
20 min 99.90 0.31 99.93 0.25 99.93 0.25 -1.28 0.32 0.50 0.32 NS
25 min 99.57 1.85 99.60 1.85 99.97 0.18 -1.15 0.47 0.14 0.12 NS
30 min 99.90 0.31 99.93 0.25 99.90 0.31 -1.15 0.32 0.32 0.50 NS
45 min 100.00 0.00 99.93 0.25 99.90 0.31 1.66 0.08 0.32 0.07 NS
60 min 100.00 0.00 99.60 1.85 99.83 0.53 1.37 0.12 0.25 0.05 NS
75 min 100.00 0.00 99.93 0.25 99.93 0.25 1.66 0.08 0.50 0.08 NS
90 min 99.97 0.18 99.90 0.31 99.90 0.40 1.15 0.15 0.50 0.21 NS
105 min 99.93 0.37 99.77 0.63 99.87 0.43 1.41 0.11 0.24 0.26 NS
120 min 99.97 0.18 99.93 0.37 100.00 0.00 0.51 0.33 0.16 0.16 NS
59
 100
90
80
70
Mean SPO2

60
50
40
30
20
10
0

TIME INTERVAL

Group A Group B Group C

The above table shows mean saturation of peripheral oxygen in all the
groups, mean SpO2 in group A, mean SpO2 in group B and mean SpO2 group C at
all time points was found to be comparable and difference between three groups
was statistically non significant (p >0.05).

60
 DISCUSSION

Shivering is a common post anaesthetic occurrence which is defined as

involuntary repetitive activity of skeletal muscle. It is a common and distressing
experience to many patients which occur either during or immediately after the
surgery. The incidence of shivering following spinal anaesthesia is 30-60%. Spinal
anaesthesia is widely used as safe anaesthesia technique for both elective and
emergency operations including all open gynaecology and obstetric surgery,
orthopedic and plastic surgery of lower limb and pelvis, general surgery of pelvis
and lower abdomen and majority of urological procedure.2

The main causes of intra operative or post operative shivering are heat loss,
increased sympathetic tone, pain and systemic release of pyrogens. Shivering is
potentially serious complication that occurs in 20-70% of the surgeries in post
operative period. The shivering can increase metabolic rate, increased oxygen
consumption (upto 100-600%) and increased carbon dioxide production, increased
ventilation and increased cardiac output. It causes arterial hypoxemia, lactic
acidosis, increased intraocular pressure and intracranial pressure. Shivering itself
interferes with pulse rate, blood pressure and ECG monitoring.3

It is a physiological response to core heat production. The core body

temperature is maintained within range of 36.5-37.5o C which is known as thermo-
neutral zone. Thermo regulatory response like vasoconstriction and shivering are
activated when core body temperature falls below normal range. 4 The spinal α
motor neurons and their axons mediate the neurological mechanism of shivering
with centre at pre-optic nucleus of the anterior hypothalamus.5

After spinal anaesthesia shivering is more common than after general

anaesthesia as vasoconstriction effect after heat loss during surgery is lost when
patient in under spinal anaesthesia due to sympathetic blockade.

Pathogenesis: Inhibition of thermo-regulation and non thermo-regulatory

mechanism, pain, uncontrolled spinal reflexes and cutaneous vasodilation.

61
 There are many non pharmacological and pharmacological methods to
control shivering. The non pharmacological methods include use of warm blankets,
warm iv fluids, use of external warmer, warming of skin surface.

The aim of the present study was to compare the effect of tramadol, clonidine
and dexmedetomidine IV for the control of post operative shivering after surgery
under spinal anaesthesia.

In a randomised double blinded manner, 90 patients were taken of ASA

grade I and II in the age group of 18-60 years. The patient were randomly allocated
in 3 groups with 30 patient in each group.

Group A will receive tramadol 1 milligram /kg body weight IV.

Group B will receive clonidine 1 microgram/kg body weight IV.

Group C will receive dexmedetomidine 0.5 microgram/kg body weight IV.

The hemodynamic monitoring was continued after the administration of

these drugs. Baseline pulse rate, blood pressure, SpO2, shivering grade, sedation
scale and side effects were recorded.

PATIENT CHARACTERISTICS:

AGE:-

In present study, patients included in all three groups were in the age group
of 18-60 years of age. The mean age in group A was 40.03±10.29 years, Group B
was 38.86±12.22 years and Group C was 39.46±9.12 years. The p-value between
Group A and B was 0.821, Group B and C was 0.761, Group A and C was 0.711.

The difference in mean age group in all three groups was found to be
statistically non significant (p>0.05).

62
SEX:-

Our study included patients of both sexes i.e. male and female. The
difference in sex wise distribution in all the three groups was found to be statistically
non significant (p>0.05).

ASA GRADE:-

In our study we included the patients of ASA grade I and II only. Group A
had twenty one patients under ASA grade I and nine patients under ASA grade II,
Group B had twenty one patients under ASA grade I and nine patients under ASA
grade II, Group C had twenty four patients under ASA grade I and six patients under
ASA grade II. The difference in the ASA grade in all three groups was found to be
statistically non significant.

DISTRIBUTION ACCORDING TO THE SURGICAL PROCEDURE

PERFORMED:-

The patients included in our study in all three groups were compared with
respect to type of surgical procedure performed. The difference in the surgical
procedure performed in all three groups was found to be statistically non significant.

TIME TAKEN BY THE DRUG ADMINSTERED TO CONTROL OF SHIVERING:-

In our study, the mean time taken by the drug to control of shivering. Group
C was 2.8±0.12 minutes, Group A was 5.20±0.34 minutes whereas Group B was
i.e. 6.14±0.41 minutes. Group C take least time whereas group B take more time
for control of shivering. The difference between Group A and B, Group B and C,
Group A and C is statistically highly significant (p<0.001).

Similar study has been conducted by Kundra TS et al in 2017 to compare

the efficacy of dexmedetomidine and tramadol on post spinal anaesthesia
shivering. They concluded that time to cessation of shivering was significantly less
with dexmedetomidine 2.9±0.23 minutes than with tramadol 4.6±0.40minutes
(p<0.001). The difference between the groups was statistically highly significant.63

63
 In a similar study done by the Reddy VS et al in 2011 to compare clonidine
and tramadol for post spinal shivering in caesarean section. They concluded that
time to cessation of shivering was significantly less with tramadol 2.2±0.41 minutes
than with clonidine 3.17±0.03 minutes (p<0.05). The difference between these
group was highly significant.56

Mittal G et al conduced a similar study in 2014 to compare dexmedetomidine

and tramadol for post spinal shivering. They concluded that time for cessation of
shivering was significantly less in dexmedetomidine 2.52±0.44 minutes than
tramadol 5.92±0.81 minutes (p<0.002). The difference between these groups was
statistically significant.60

A similar comparative study done by Paneer M et al in 2017 to compare the

intravenous dexmedetomidine and intravenous clonidine for post spinal shivering in
patients undergoing lower limb orthopaedic surgery. They concluded that time
taken for cessation of shivering was significantly less with dexmedetomidine
2.23±0.43minutes than clonidine 5.54±0.58 minutes (p<0.01). The difference
between these groups was statistically significant.62

A similar comparative study was done by Verma A et al in 2018 to evaluate

dexmedetomidine and tramadol for attenuation of post spinal anaesthesia
shivering. They concluded that time taken for cessation of shivering of significantly
less with dexmedetomidine 2.95±1.18 minutes than in tramadol 7.15±1.77 minutes
(p<0.05). The difference between these groups was statistically significant.64

BRADYCARDIA:-

In our study bradycardia was observed in all three groups. Group C has 6
patients (20%), Group B has 3 patients (10 patients) and Group A has 2 patient
(6.67%). Hence difference between these groups was statistically non significant.

Similar study have been done by Kundra TS et al in 2017, on comparing the

efficacy of dexmedetomidine and tramadol on post spinal shivering. They
concluded that dexmedetomidine has one case of bradycardia as compared to

64
tramadol (p=0.31). The difference between these groups was statistically non
significant.63

A similar study have been done by Verma A et al in 2018, to compare

dexmedetomidine and tramadol for attenuation of post spinal anaesthesia
shivering. They concluded that dexmedetomidine has three cases of bradycardia
as compared to tramadol (p=0.24). The difference between these groups was
statistically non significant.64

Similar study has been done by Wason et al in 2012 to compare the effect
of prophylactic ketamine, clonidine and tramadol for control of shivering under
neuraxial anaesthesia. They concluded that clonidine has three cases of
bradycardia as compare to tramadol (p=0.791). The difference between these
groups was statistically non significant.67

Similar study have been done by Singla A et al 2017 on efficacy and safety
of tramadol and dexmedetomidine in treatment of shivering following spinal
anaesthesia (randomised controlled study). They concluded that dexmedetomidine
has 6 cases of bradycardia as compared to tramadol (p>0.05). The difference these
group was statistically non significant.61

NAUSEA AND VOMITING:

In our study, nausea and vomiting was observed in all three groups Group A
had 10 patients (33.33%), Group B had 1 patient (3.33%) and Group C had 1 patient
(3.33%). The difference between Group A and B, Group A and C was statistically
highly significant but difference between Group B and C was found statistically non
significant.

Similar study have done by Kundra TS et al in 2017 to compare the efficacy

of dexmedetomidine and tramadol on post spinal anaesthesia shivering. They
concluded that fourteen cases of nausea and vomiting were observed in tramadol
as compared to dexmedetomidine (p<0.001). The difference between these groups
was statistically highly significant.63

65
 Similar study have been done by the Mittal GS et al in 2014 to compare
dexmedetomidine and tramadol for post spinal shivering. They concluded that
seven cases of nausea and vomiting was observed in tramadol as compare to
dexmedetomidine. The difference between these groups was statistically
significant.60

Similar study have been done by Verma A et al in 2018 on comparative

evaluation of dexmedetomidine and tramadol for attenuation of post spinal
anaesthesia shivering. They concluded that 23 cases of nausea and vomiting was
observed in tramadol as compared to dexmedetomidine (p<0.001). The difference
between these groups was highly significant.64

Similar study have been done by Wang et al in 2020 on intravenous

dexmedetomidine versus tramadol for treatment of shivering after spinal
anaesthesia (randomised controlled trial). They concluded that 41 cases of nausea
and vomiting was observed in tramadol as compared to dexmedetomidine
(p<0.001). The difference between these groups was statistically highly
significant.66

Similar study have been done by Singla A et al in 2017 on efficacy and safety
of tramadol and dexmedetomidine in treatment of shivering following spinal
anaesthesia (randomised controlled study). They concluded that 25 cases of
nausea and vomiting was observed in tramadol as compared to dexmedetomidine
(p<0.001). The difference between these groups was statistically significant.61

In double blind study done by the Reddy VS et al in 2011 on clonidine versus

tramadol for post spinal shivering caesarean section. They concluded that nausea
and vomiting was highly significant in tramadol as compared to clonidine. The
difference between these groups was statistically significant.56

Similar study have been done by Ramesh K et al in 2019 on comparative

study between intravenous dexmedetomidine and tramadol for control of post spinal
shivering. They concluded that tramadol has high incidence of nausea and vomiting
as compare to dexmedetomidine (p<0.001). The difference between these groups
was statistically significant.68

66
SEDATION SCORE:-

In our study, sedation score was compared between Group A, Group B and
Group C. The difference between Group A and Group C was statistically significant
but difference between Group A and Group B, Group B and Group C was found
statistically non-significant.

Similar study done by Ramesh K et al in 2019 on clinical comparative study

between intravenous dexmedetomidine and a tramadol for the control of post spinal
anaesthesia shivering. They concluded that patients in dexmedetomidine were
more sedated than tramadol (p-value<0.001). The difference between these groups
was statistically highly significant.68

Similar study have been done by Wang et al in 2020 on intravenous

dexmedetomidine versus tramadol for treatment of shivering after spinal
anaesthesia (randomised controlled trial). They concluded that patients in
dexmedetomidine had higher incidence of sedation as compared to tramadol
(p=0.005). The difference between groups was statistically significant. 66

Similar study have been done by Verma A et al in 2018 on comparative

evaluation of dexmedetomidine and tramadol for attenuation of post spinal
anaesthesia shivering. They concluded that sedationś profile between these
groups i.e. tramadol and dexmedetomidine (p<0.001). The difference between
these groups was statistically significant.64

Similar study have been done by Singla A et al in 2017 on efficacy and safety
of tramadol and dexmedetomidine in treatment of shivering following spinal
anaesthesia (randomised controlled study). They concluded that patients received
dexmedetomidine has high incidence of sedation as compared to tramadol
(p<0.001). The difference between groups was highly statistically significant. 61

Similar study have been done by Verma NK et al 2016 on comparison of

clonidine, dexmedetomidine and tramadol for control of post spinal shivering (RCT).
They concluded that patients received dexmedetomidine was more sedated than
tramadol (p<0.05). The difference between groups was statistically significant. 69

67
 Similar study done by Ameta N et al 2018 to compare prophylactic use of
ketamine, tramadol and dexmedetomidine for prevention of shivering after spinal
anaesthesia. They concluded that dexmedetomidine has higher incidence of
sedation than tramadol (p<0.05). The difference between groups was statistically
significant.70

Similar study done by Bozgeyik et al in 2014 on effects of pre-emptive

tramadol and dexmedetomidine on shivering during arthroscopy. They concluded
that sedation with dexmedetomidine was higher as compare to tramadol (p=0.04).
The difference between groups was statistically significant.59

Similar study have been done by Paneer M et al in 2017 to compare

intravenous dexmedetomidine and intravenous clonidine for post spinal shivering in
patients undergoing lower limb orthopaedic surgery. They concluded that level of
sedation was better with dexmedetomidine as compare to tramadol. The difference
between these groups was statistically significant.62

In a comparative study done by Kundra TS et al in 2017 on the efficacy of

dexmedetomidine and tramadol on post spinal anaesthesia shivering. They
concluded that dexmedetomidine causes more sedation than tramadol (p<0.001).
The difference between these groups was statistically significant.63

HYPOTENSION:-

In our study, hypotension was observed in 11 patients (36.67%) in group C,

8 patients (26.67%) in group B and 5 patients (16.67) in group A. Hence difference
between these groups was statistically non significant (p value >0.05).

Similar study was done by Verma A et al in 2018 to compare

dexmedetomidine and tramadol for attenuation of post spinal anaesthesia
shivering. They concluded that hypotension was observed in 3 cases of tramadol
as compared to dexmedetomidine. Hence the difference between these groups was
statistically non significant (p=0.24).64

Similar study has been done by Wason et al in 2012 (randomised double

blind) to compare prophylactic ketamine, clonidine and tramadol for control of

68
shivering under neuraxial anaesthesia. They concluded that hypotension observed
in 16 cases of clonidine as compared to tramadol. Hence the difference between
these groups was statistically non significant (p=0.631).67

Similar study was done by Shukla U et al in 2011 to compare the effect of

clonidine and tramadol on post-spinal anaesthesia shivering. They concluded that
hypotension was observed in 3 cases of clonidine as compared to tramadol. Hence
the difference between these groups was statistically non significant (p=0.077). 55

Similar study done by Singla A et al in 2017 on efficacy and safety of

tramadol and dexmedetomidine in treatment of shivering following spinal
anaesthesia (randomised controlled study). They concluded that hypotension
between tramadol and dexmedetomidine was statistically non significant
(p=0.407).61

HEART RATE:-

In our study the heart rate of patients in Group A, B, C at different time

interval. Mean heart rate at baseline (0 min) was 79.33±6.22 in Group A, Group B
81.57±9.06 and in Group C 81.60±6.29. Heart rate was recorded at 2 minutes, 4
minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30
minutes and then regularly at 15 minutes interval till 120 minutes. Although
bradycardia was recorded in 6 patients, 3 patients and 2 patients in group A, B, A
respectively but the difference between mean heart rate of patients in all three
groups did not statistically differ at any time points of the study. (p>0.05).

SYSTOLIC BLOOD PRESSURE:-

In our study the systolic blood pressure of patients in Group A, B, C at

different time interval. Mean systolic blood pressure at baseline (0 min) was
122.60±12.76 in Group A, Group B 120.07±9.52 and in Group C 124.87±13.23.
Systolic Blood pressure was recorded at 2 minutes, 4 minutes, 6 minutes, 8
minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes and then
regularly at 15 minutes interval till 120 minutes. The difference between systolic
blood pressure of patients in three groups did not statistically differ at any time
points of the study. (p>0.05).

69
DIASTOLIC BLOOD PRESSURE:-

In our study the diastolic blood pressure of patients in Group A, B, C at

different time interval. Mean diastolic blood pressure at baseline (0 min) was
76.97±9.57 in Group A, Group B 78.47±8.35 and in Group C 76.37±8.66. Diastolic
Blood pressure was recorded at 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10
minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes and then regularly at 15
minutes interval till 120 minutes. The difference between diastolic blood pressure
of patients in three groups did not statistically differ at any time points of the study.
(p>0.05).

SpO2:-

In our study the mean saturation of peripheral oxygen of patients in Group A

B, C at different time interval. Mean saturation of peripheral oxygen at baseline (0
min) was 99.87±0.43 in Group A, Group B 99.87±0.43 and in Group C 99.93±0.25.
Mean saturation of peripheral oxygen was recorded at 2 minutes, 4 minutes, 6
minutes, 8 minutes, 10 minutes, 15 minutes, 20 minutes, 25 minutes, 30 minutes
and then regularly at 15 minutes interval till 120 minutes. The difference between
mean saturation of peripheral oxygen of patients in three groups did not statistically
differ at any time points of the study. (p>0.05).

RECURRENCE OF SHIVERING
In our study the recurrence of shivering was observed in 7 patients (23.33%)
Group A, 3 patients (10.00%) Group B and 2 patients (6.67%) Group C. hence
difference between these groups was statistically non significant (p value >0.005).

Similar study have been done by Kundra TS et al in 2017 to compare the

efficacy of dexmedetomidine and tramadol on post spinal shivering. They
concluded that recurrence rate of shivering was less with dexmedetomidine as
compared to tramadol. The difference between these groups was statistically non
significant (p=0.110).63

Similar study have been done by the Mittal G et al in 2014 (randomised

double blind) to compare dexmedetomidine and tramadol for post spinal shivering.
They concluded that recurrence of shivering was higher in tramadol group as

70
compare to dexmedetomidine. The difference between these groups was
statistically non significant (p=0.551).60

Similar study was done by Bansal P et al in 2011 on comparative study for

control of shivering with clonidine, butorphanol, and tramadol under spinal
anaesthesia. They concluded that recurrence of shivering was higher in tramadol
group as compare to clonidine and butorphanol. The difference between these
groups was statistically non significant (p=0.77).54

Similar study was done by Shukla U et al 2011 on a comparative study of

the effect of clonidine and tramadol on post-spinal anaesthesia shivering. They
concluded that recurrence of shivering was higher in tramadol group as compare to
clonidine. The difference between these groups was statistically non significant
(p=0.152).55

Similar study have been done by Ramesh K et. al. 2019 on comparative
study between intravenous dexmedetomidine and tramadol for control of post spinal
shivering. They concluded that recurrence of shivering was higher in tramadol
group as compare to dexmedetomidine. The difference between these groups was
statistically non significant.68

Similar study have been done by Verma A et al in 2018 to evaluate

dexmedetomidine and tramadol for attenuation of post spinal anaesthesia
shivering. They concluded that recurrence of shivering was higher in tramadol
group as compare to dexmedetomidine. The difference between these groups was
statistically non significant.64

TIME OF ONSET OF SHIVERING

In our study mean time for onset of shivering in Group A was 23.2±6.38
minutes, Group B was 24.66±7.12 and Group C was 25.2±6.96 minutes. The
difference between the groups was statistically non-significant (p>0.05).

Similar study was done by Shukla U et al in 2011 to compare the effect of

clonidine and tramadol on post-spinal anaesthesia shivering. They concluded that

71
mean time onset of shivering between two groups i.e. clonidine and tramadol was
statistically non significant (p=0.43).55

In a similar study done by Kundra TS et al in 2017 to compare the efficacy

of dexmedetomidine and tramadol on post spinal shivering. They concluded that
mean time onset of shivering between tramadol and dexmedetomidine was
statistically non significant.63

In a comparative study done by Ramesh K et al in 2019 compared

intravenous dexmedetomidine and tramadol for control of post spinal shivering.
They concluded that mean time onset of shivering between tramadol and
dexmedetomidine was statistically non significant.68

Similar randomized double blind study was done by the Mittal G et al in 2014
to compare dexmedetomidine and tramadol for post spinal shivering. They
concluded that mean time onset of shivering between tramadol and
dexmedetomidine was statistically non significant (p=0.71).60

SHIVERING CONTROL:

In our study control of shivering was observed in all 3 groups. Group A 30

patient (100%) had complete control, group B 22 patients (73.33%) had complete
control and 8 patients (26.67%) had complete control whereas in group C 27
patients (90%) had complete control and 3 patients (10%) had incomplete control.
The difference between group A and B was highly significant but the difference
between group B versus group C and group A versus group C was statistically non
significant.

72
 SUMMARY

The present study titled as “COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA”
and was carried out in Department Anaesthesiology and Critical Care, Govt.
Medical College, Amritsar.

The aim of the study was to compare the effect of tramadol, clonidine and
dexmedetomidine for the control of postoperative shivering after surgery under
spinal anaesthesia

In a randomized double blinded manner, 90 patients were taken of ASA

grade I and II in the age group of 18-60 years. The patient were randomly allocated
in three groups with 30 patients in each groups.

Group A will receive tramadol 1mg/kg body weight IV

Group B will receive clonidine 1 μg/kg body weight IV

Group C will receive dexmedetomidine 0.5μg/kg body weight IV

The hemodynamic monitoring was continued after the administration of

these drugs. Baseline blood pressure, pulse rate, respiratory rate, SPO2, shivering
grade and sedation scale were assessed.

PRIMARY AIM:

 To study the effect of tramadol, clonidine and dexmedetomidine in post

operative shivering.

SECONDARY AIM:

 To compare the effect of tramadol, clonidine and dexmedetomidine on

haemodynamics.

 To compare the adverse effects among all three drugs.

73
The results of our study were as follows:

 The three groups were comparable in the view of demographic data and
patient characteristics.

 The mean time taken to control shivering in Group C was 2.8±0.12 min,
Group A was 5.2±0.41 minutes and Group B was 6.14±0.41. Group C take
least time whereas Group B take more time to control shivering. The group
show highly statistically significant difference (p<0.001).

 The mean time for onset of shivering in Group A was 23.3±6.38 min, Group
B was 24.66±7.12 and Group C was 25.20±6.96 minutes. The difference
between the groups was statistically non significant.

 The sedation achieved with dexmedetomidine was better than clonidine and
tramadol.

 Nausea and vomiting was more than tramadol as compared to clonidine and
dexmedetomidine.

 Bradycardia and hypotension was more with dexmedetomidine as compared

to tramadol and clonidine.

 The three groups were found to be comparable with respect to

hemodynamics like BP, PR, SPO2 with the difference being statistically non
significant.

74
 LIMITATIONS

 Smaller sample size

 Double blinded study

75
 CONCLUSION

In conclusion, all drugs in this study namely tramadol 1mg/kg IV, clonidine
1μg/kg IV and dexmedetomidine 0.5μg/kg IV effectively treated post spinal
shivering. But mean time taken by the dexmedetomidine in control of shivering was
least i.e. 2.8 min as compared to other drugs and recurrence rate is also less with
dexmedetomidine.

There was no statistically significant difference in hemodynamic changes in

all three groups.

76
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46. Powell RM, Buggy DJ. Ondansetron given before induction of anesthesia
reduces shivering after general anaesthesia. Anesth Analg. 2000;90(6):
1423-7.

47. Alojado ME, Ohta Y, Kemmotsu O. The effect of clonidine on the activity of
neurons in the rat’s dorsal raphe nucleus in vitro. Anesth Analg. 1994;79(2):
257-60.

48. Timmermans PB, Brands A, Van Zwietan PA. Lipophilicity and brain
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49. Klimecsha W, Tong C, Eisenach JC. Intrathecal alpha-2 adrenergic agonist
stimulate acetylcholine and norepinephrine release from the spinal cord
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1997;87(1):110-6.

50. Delaunay L, Bonnet F, Liu N, Beydon L, Catoire P, Sessler DI. Clonidine

comparably decreases the thermoregulatory thresholds for vasoconstriction
and shivering in humans. J Am Soc Anesthesiol. 1993;79(3):470-4.

51. Chan AMH, Jacobus NG, Tong EW, Jan GSK. Control of shivering under
regional anaesthesia in obstetric patients with tramadol. Can J Anaesth.
1999;46[3]:253-8.

52. Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and meperidine
for postepidural anesthetic shivering in parturients. Anesth & Analg. 2001;
93(5):1288-92.

53. Mohta M, Kumari N, Tyagi A, Sethi AK, Agarwal D, Singh M. Tramadol for
prevention of postanaesthetic shivering: a randomised double‐blind
comparison with pethidine. Anaesth. 2009;64(2):141-6.

54. Bansal P, Jain G. Control of shivering with clonidine, butorphanol, and

tramadol under spinal anesthesia: a comparative study. Local and Regional
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55. Shukla U, Malhotra K, Prabhakar T. A comparative study of the effect of

clonidine and tramadol on post-spinal anaesthesia shivering. Ind J Anaesth.
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56. Reddy VS, Chiruvella S. Clonidine versus tramadol for post spinal shivering
during caesarean section: A randomized double blind clinical study. J Obstet
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57. Usta B, Gozdemir M, Demircioglu RI, Muslu B, Sert H, Yaldiz A.

Dexmedetomidine for the prevention of shiveringduring spinal anesthesia.
Clinics. 2011;66:1187-91.

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58. Yousuf B, Samad K, Ullah H, Hoda MQ. Efficacy of tramadol in preventing
postoperative shivering using thiopentone or propofol as induction agent: A
randomized controlled trial. J Anaesthesiol, Clin Pharmacol. 2013;29(4):521.

59. Bozgeyik S, Mizrak A, Kılıç E, Yendi F, Ugur BK. The effects of preemptive
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60. Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind

comparative study of dexmedetomidine and tramadolfor post-spinal
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61. Singla A, Chaudhari M, Patel A. Efficacy and safety of tramadol and

dexmedetomidine in treatment of shivering following spinal anaesthesia: a
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62. Panneer M, Murugaiyan P, Rao SV. A comparative study of intravenous

dexmedetomidine and intravenous clonidine for postspinal shivering in
patients undergoing lower limb orthopedic surgeries. Anesth Essays Res.
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63. Kundra TS, Kuthiala G, Shrivastava A, Kaur P. A comparative study on the

efficacy of dexmedetomidine and tramadol on post-spinal anesthesia
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of Dexmedetomidine and Tramadol for Attenuation of Post-Spinal
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65. Venkatraman R, Karthik K, Pushparani A, Mahalakshmi A. A prospective,

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66. Wang J, Wang Z, Liu J, Wang N. Intravenous dexmedetomidine versus
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67. Wason R, Jain N, Gupta P, Gogia AR. Randomized double-blind comparison

of prophylactic ketamine, clonidine and tramadol for the control of shivering
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68. Ramesh K, Bhushanam KN, Sharma BA, Kumar SS. A clinical comparative
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84
1
GROUP A (TRAMADOL)

Time from drug administration to control of shivering

Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

1 LB 40 M 1659 I LTFMH 108 Variconse Vein 24 4 28 4.87 No Yes Yes Yes

2 GS 35 M 1638 II Orchidectomy 110 Scrotal abscess 25 4 29 4.88 Yes Yes No No
3 NMK 36 F 84156 I THR 140 Fracture NOF 25 4 28 4.92 No Yes No No
4 AS 24 M 84290 II External Fixator 118 Fracture Femur 26 3 30 4.92 No Yes No No
5 SS 55 M 1650 I LTFMH 110 Inguinal hernia 23 4 30 4.89 Yes Yes Yes Yes
6 VS 33 M 1572 I Hemorrhoidectomy 110 External hemorroids 24 4 22 5.2 No No No No
7 HS 35 M 1549 I LTFMH 110 Inguinal hernia 24 4 29 5.12 No No No No
8 DS 45 M 1647 I Fistulectomy 110 Fistula in ano 24 4 219 5.16 No No No Yes
9 RK 40 M 1663 I Fistulectomy 110 Fistula in ano 25 4 29 5.14 No No Yes No
10 BK 35 M 1620 I Hernia Repair 110 Umblical Hernia 26 4 29 5.2 No No No No
11 BS 30 M 84132 I Hemorrhoidectomy 110 Hemorroids 26 4 29 5.24 No No No Yes
12 SS 35 M 1665 I Skin Grafting 110 Degloving injury 26 4 29 5.3 No No Yes No
13 GS 40 M 84549 I ILN Tibia 120 Fracture Right Tibia 26 3 29 5.32 No No No No
14 HK 25 M 1460 I Meatoplasty 110 Urethal Meatus 26 4 30 5.4 No No No No
15 GS 28 M 80723 I ILN Tibia 98 Fracture Right Tibia 26 4 29 5.42 No No Yes Yes
16 GS 50 M 400 II Stoma Closure 90 Post exp lap 25 3 30 5.15 No No No No
17 GS 38 M 352 I Stoma Closure 90 Post exp lap 26 4 29 5.26 No No Yes No
18 SS 55 M 318 I Incision and Drainage 90 Testicular abscess 26 4 29 5.42 No No No No
19 NS 52 M 80662 I Incision and Drainage 110 Testicular abscess 24.4 4 29 5.41 No No Yes Yes
2
GROUP A (TRAMADOL)

Time from drug administration to control of shivering

Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

20 SS 30 M 377 II Excision 110 Swelling anterior thigh 25.6 3 30 5.39 No No No No

21 JS 40 M 80497 I LTFMH 90 Inguinal hernia 26.2 4 29 5.5 No No Yes No
22 JK 35 F 218 I Ileostomy Reversal 94 Post exp lap with ileostomy 24.2 4 29 5.52 No No No Yes
23 LS 30 M 79977 II Debridement 90 both bone fracture 26.2 4 29 5.54 No No Yes No
24 JS 28 M 99977 II Trochanteric pin adjustment 90 right acetabular fracture 27.2 3 29 5.49 No No No No
25 DS 40 M 80610 I Implant Readjustment 88 Tibia Fracuter 26.2 4 29 5.43 No No No No
26 DM 45 M 80583 II Right DFLP 120 Fracture Femur 25.6 4 29 5.2 No No No No
27 BS 410 M 80539 I ILN Tibia 130 Fracture Tibia 25.6 4 29 5.31 No No Yes No
28 JS 48 M 80518 II Debridement 110 Gangrene of foot 25.8 4 29 5.32 No No No No
29 RS 28 M 80528 I Delta Frame right fibula 110 Fracture Right Fibula 27.4 4 29 5.33 No No No No
30 LS 30 M 328 II ILN Tibia 110 Fracture Right Tibia 27.3 4 29 5.44 No No No No
3
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 77 79 79 81 77 79 95 80 79 75 76 75 77 90 81 90 119 100 113 116 117 117 119 119 121 114 119 121 119 121 113 125
2 81 83 85 83 79 81 90 75 79 83 84 76 80 85 77 85 113 100 111 130 113 116 69 113 116 115 113 116 113 113 115 120
3 73 71 69 73 71 69 71 75 71 69 73 75 69 85 71 75 138 125 132 133 137 131 138 137 137 131 138 137 138 137 133 128
4 67 69 71 67 65 67 95 85 71 67 69 71 67 75 72 80 127 96 128 131 123 124 127 123 126 124 127 126 127 124 126 124
5 71 69 67 69 66 70 95 80 71 69 71 85 66 85 73 88 124 123 121 125 113 121 124 113 121 121 124 121 124 124 121 120
6 72 69 73 66 66 69 90 90 72 71 72 71 67 90 72 95 120 119 128 122 109 127 121 109 119 127 121 119 121 122 128 123
7 83 74 82 81 85 85 85 85 85 85 83 83 86 95 85 90 148 123 155 147 149 149 149 149 147 149 149 147 149 151 153 124
8 98 79 84 90 83 90 91 90 90 91 89 81 91 80 91 80 129 130 133 121 129 129 129 129 123 131 129 123 129 131 133 120
9 79 69 79 86 87 87 86 85 87 87 90 79 86 85 87 85 119 125 117 116 117 135 111 118 116 113 117 116 113 119 117 120
10 87 70 89 86 90 87 89 79 87 87 86 87 89 86 87 82 127 125 121 125 125 130 121 119 119 123 121 119 125 123 125 124
11 85 77 73 85 85 85 87 85 85 85 87 85 87 95 86 75 126 119 123 121 124 121 128 123 121 129 121 121 124 126 121 130
12 87 79 76 89 83 90 91 83 90 85 93 87 91 75 90 98 128 130 128 129 128 121 133 128 121 133 131 121 128 128 129 125
13 76 76 71 83 89 83 86 90 83 83 79 76 86 90 83 80 139 120 137 141 137 139 141 137 139 139 137 139 139 131 141 124
14 85 91 72 85 85 85 89 85 85 87 85 85 89 85 85 75 117 123 117 135 115 116 116 117 116 116 117 135 115 117 116 126
15 80 76 79 87 87 87 90 87 87 87 83 80 90 85 86 85 127 131 127 121 127 119 119 127 119 121 127 119 127 127 121 124
16 81 84 71 86 75 87 84 88 87 89 91 81 84 90 86 75 109 125 111 111 109 130 111 130 111 111 111 130 109 109 111 128
17 71 82 83 86 75 85 89 85 85 85 79 71 89 95 85 90 127 120 127 129 125 129 121 127 129 120 131 129 125 127 129 134
18 79 74 76 89 82 81 86 95 81 81 81 79 86 90 81 85 137 140 138 139 139 137 137 133 137 135 139 137 139 139 139 128
19 71 75 81 83 80 79 81 92 79 79 85 82 81 85 80 96 108 132 102 111 111 109 111 110 113 111 105 113 135 105 105 132
4
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 77 72 72 85 76 81 81 76 81 89 81 88 81 81 81 84 125 130 122 129 121 128 131 130 128 129 125 128 121 125 129 134
21 81 69 91 91 90 90 91 82 90 89 86 85 91 72 90 82 130 127 141 141 143 137 141 118 137 141 141 137 143 139 141 136
22 79 91 76 89 84 89 75 72 89 89 81 92 88 85 86 75 111 120 119 115 119 115 115 135 119 135 119 119 119 117 119 120
23 75 72 75 79 76 77 78 92 77 77 79 98 78 90 77 74 117 119 117 119 119 119 121 117 119 140 117 119 119 117 119 131
24 81 86 85 87 81 87 85 80 87 87 83 81 86 85 87 82 99 113 105 130 113 113 111 109 135 109 105 130 111 111 111 120
25 81 78 78 87 85 85 90 75 85 87 87 96 87 90 85 75 103 120 113 109 115 115 103 140 115 115 117 115 135 140 105 124
26 75 77 81 89 98 83 90 75 83 83 89 75 81 89 82 95 109 129 110 111 111 125 109 130 111 111 109 111 111 109 111 129
27 81 69 82 87 87 87 75 75 87 89 85 90 88 88 87 70 147 133 151 153 151 149 149 120 149 147 151 149 151 149 143 129
28 85 69 72 81 79 79 80 80 79 79 79 82 80 90 79 85 139 119 141 135 141 139 141 141 146 139 141 146 141 139 147 124
29 79 76 73 79 88 79 98 79 79 79 86 92 81 86 79 96 109 125 111 113 109 113 111 111 117 113 111 117 130 109 113 126
30 83 77 81 86 85 85 86 95 85 85 91 83 86 91 86 94 107 130 109 125 107 130 99 109 130 130 109 130 107 130 103 120
5
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 69 73 73 80 69 69 69 67 75 75 75 71 80 73 69 79 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
2 77 85 73 95 79 78 95 78 77 81 81 79 80 95 80 77 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
3 81 85 79 81 81 81 81 89 83 83 83 83 81 81 87 72 100 99 99 99 100 100 100 100 100 100 100 100 100 100 100 100
4 109 77 69 76 109 109 109 101 77 77 77 107 88 76 100 80 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
5 81 85 80 81 81 81 81 90 79 79 79 83 81 81 87 78 100 100 100 100 100 99 100 100 100 100 100 100 100 100 100 100
6 89 80 78 78 91 89 89 88 77 77 77 87 70 78 89 74 100 100 100 100 100 100 99 99 100 100 100 100 100 100 100 100
7 91 91 75 97 93 91 91 93 99 99 99 93 80 97 95 76 100 100 100 100 99 100 100 100 100 100 100 100 100 100 100 100
8 79 88 82 99 88 79 79 78 97 97 97 81 78 99 79 77 100 100 100 100 100 100 100 100 99 100 100 100 100 100 100 100
9 68 80 78 73 82 67 65 66 71 66 66 65 80 73 68 76 100 100 100 100 100 100 100 100 100 99 100 100 100 100 100 100
10 67 65 69 68 65 71 68 68 68 69 69 68 80 68 69 80 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
11 71 75 79 82 71 61 71 73 71 69 69 71 85 73 71 86 99 100 99 100 100 100 100 100 100 100 100 100 100 100 100 100
12 63 72 77 78 80 69 64 64 64 61 86 64 82 64 65 85 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
13 89 85 73 85 82 91 85 90 89 81 81 85 82 85 83 89 100 99 100 99 100 100 100 100 100 100 100 100 100 100 100 100
14 71 80 78 69 88 69 71 69 71 69 72 71 85 69 69 75 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
15 69 81 79 78 79 77 71 73 77 77 77 73 87 78 78 85 100 100 100 100 100 98 99 99 100 100 100 100 100 100 100 100
16 79 79 70 81 81 77 81 81 81 77 77 81 84 81 81 76 100 100 100 100 100 100 100 100 98 99 100 100 100 100 100 100
17 85 71 63 81 85 81 78 89 89 83 83 83 72 81 89 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
18 81 87 61 79 89 88 85 89 79 89 89 85 82 79 79 70 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
19 61 85 69 68 82 69 79 68 68 69 80 79 85 68 68 78 99 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
6
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 79 81 65 81 79 75 87 81 81 75 75 87 86 81 83 85 100 100 99 100 99 100 100 100 100 100 100 100 100 100 100 100
21 89 77 67 83 89 88 81 81 91 88 88 83 80 83 89 70 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
22 69 82 67 71 87 66 73 71 71 66 88 73 78 71 71 85 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
23 73 71 69 75 75 75 71 75 75 75 75 71 86 75 75 81 100 99 100 99 100 100 100 100 100 100 100 100 100 100 100 100
24 77 65 81 81 69 75 73 79 81 69 69 83 95 81 79 77 100 100 100 100 100 100 99 99 100 99 100 100 100 100 100 100
25 63 87 83 65 86 69 67 65 65 69 69 69 88 65 65 79 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
26 69 79 77 87 69 69 69 69 67 69 82 65 72 67 69 81 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
27 91 91 89 89 89 89 72 93 93 89 89 89 89 89 93 83 98 100 99 100 100 100 100 100 100 100 100 100 100 100 100 100
28 81 71 75 85 79 77 81 83 83 77 77 81 79 85 83 78 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
29 71 80 68 73 82 71 73 71 73 71 71 73 80 73 73 75 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
30 77 88 69 81 88 75 78 80 79 75 75 78 75 81 79 69 100 100 100 100 100 100 100 100 90 100 100 100 100 100 100 100
7
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 4 4 4 4 3 3 4 4 3 4 4 4 4 4 4 4 2 3 2 2 3 3 3 3 3 3 2 2 3 2 3 3
2 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 3 3 2 3 2 2
3 4 4 4 4 4 4 4 4 4 3 3 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
4 4 4 4 4 4 4 4 4 4 4 4 3 3 4 4 4 3 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2
5 4 4 4 4 4 4 4 4 4 4 4 3 4 3 4 4 2 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2
6 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 3 3 2 3 2 3 3 3 2 2 2 2 2 2 2
7 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 3 2 2 2 3 3 2 3 2 2 2
8 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 3 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3
9 4 4 3 4 4 4 3 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
10 4 4 4 3 4 4 3 3 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
11 4 4 4 4 4 4 4 4 3 3 4 4 4 4 4 4 2 2 2 2 2 2 3 3 2 2 2 3 2 2 2 2
12 4 4 4 3 4 4 4 4 4 4 4 3 4 4 4 4 2 3 3 2 3 2 2 2 2 2 2 2 2 2 2 2
13 4 4 4 4 4 4 3 3 4 4 4 4 4 4 4 4 2 2 2 2 2 3 2 3 3 2 3 2 2 2 2 2
14 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 2 2 2 2 2 2 2 2 3 2 2 2 3 2 3
15 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
16 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 3 2 2 3 2 2 2 2 2 3 2 3 2
17 4 4 3 3 4 4 4 4 3 3 4 4 4 4 4 4 2 3 3 2 2 2 2 2 2 2 2 2 2 2 2 2
18 4 4 3 3 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 3 2 2 3 2 2 2 2
19 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
8
GROUP A (TRAMADOL)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 4 4 4 4 4 4 3 4 4 4 4 4 4 4 4 4 2 2 2 2 3 3 2 2 2 2 2 2 2 2 2 3
21 4 4 3 3 4 3 3 4 4 4 4 4 4 4 4 4 3 2 2 2 2 2 3 2 2 2 3 2 2 3 2 2
22 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 2 2 3 2 2 2 2 3 2 3 2 2 3 2 3 2
23 4 4 4 4 4 4 4 4 4 3 4 4 4 4 4 4 2 3 2 3 2 2 2 2 2 2 2 2 2 2 2 2
24 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 3 3 2 2 3
25 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 3 2 3 2 2 2 2 2 2 2
26 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 2 3 2 2 3 2 2 2 2 3 2 2 3 2 2
27 4 4 4 4 4 4 3 4 4 3 4 4 4 4 4 4 2 2 2 2 3 2 2 3 2 2 2 2 2 2 2 2
28 4 4 4 4 4 3 3 4 4 4 4 4 4 4 4 4 2 2 2 2 2 3 2 2 2 3 2 2 2 2 3 2
29 4 4 3 4 4 4 4 4 4 4 4 4 4 4 4 4 2 3 2 3 2 2 2 2 2 2 2 2 2 2 2 2
30 4 4 3 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 3 2 2 2 3 2 3 2 3 3 3 3 2 3
9
GROUP B (CLONIDINE)

Time from drug administration to control of shivering

Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

1 RS 42 M 81309 I Debridement 120 Fourniers Gangrene 25 4 29 5.74 yes yes no yes

2 NS 34 M 534 I Ileostomy Closure 120 Exp Lap 26 4 29 5.73 no no no no
3 SS 28 M 80670 I Left Tibia Locking 120 Fracture Left tibia 24 4 29 5.79 no no no no
4 MS 35 M 2249 I LTFMH 120 Rt inguinal Hernia 27 4 29 6.2 no no yes no
5 SK 21 F 81028 I ILN Tibia 120 Fracture Left tibia 27 4 29 6.21 yes no no no
6 AS 56 M 80216 II Below knee amputation 120 Wound Left Leg 25 4 29 6.33 no no no yes
7 VS 22 M 88553 II Appendectomy 111 Appendicitis 25 4 29 6.42 no yes no no
8 SS 60 M 3223 I Prostectomy 112 BPH 26 4 29 6.4 no no no no
9 BS 60 M 1661 I TKR Right Side 113 Bilateral osteoarthritis 26 4 28 6.22 yes no no yes
10 JS 55 M 1738 I Left Femur plating 114 Fracture femur 25 4 28 6.18 no yes no no
11 BC 45 F 84607 II ILN Tibia 116 Fracture both bone left leg 25 4 29 5.9 no no no no
12 SS 55 M 83673 II Femur Plating Right Side 110 Fracture femur 25 4 29 5.92 no yes no no
13 AS 50 M 81143 II Haemorrhoidectomy 120 Hemorrioids 25 4 29 6.21 no no no no
14 JK 55 M 521 I Incison drainage 100 Perineal Abscess 25 4 29 6.31 no yes no no
15 S 48 M 424 II Debridement 90 Ulcer Right Ankle 25 4 29 6.2 no no no no
16 SS 28 M 273 II Lords plication 110 Hydrocele 25 4 28 6.12 no no no no
17 HS 45 M 354 II LTFMH 110 Varicose Vein 26 4 29 5.87 no yes no no
18 GS 31 M 81287 II External fixator 110 Ankle Dislocation 26 4 29 5.88 no no no no
19 PM 24 F 80571 I External fixator femur 120 Fracture femur 26 4 29 5.82 no yes no no
10
GROUP B (CLONIDINE)

Time from drug administration to control of shivering

Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

20 MK 45 M 80176 I plating left tibia 120 Fracture Tibia 25 4 28 5.77 no no no no

21 KK 43 F 2708 I High tibial osteotomy 118 Genu Varum 25 3 29 5.82 no yes no no
22 RS 30 M 80154 I External fixator right femur 126 GCT Femur 26 3 29 5.95 no no no no
23 DK 45 F 80582 I Delta Frame Left foot 118 degloving injury 25 4 29 6.39 no no no no
24 SS 38 M 332 I ILN Tibia 128 Fracture Tibia 26 4 29 6.41 no no no no
25 RK 37 M 80585 I ILN Right Tibia 118 Fracture Left Leg 26 4 29 6.43 no no no no
26 SS 40 M 81169 I ORIF with plating 110 Fracture Fibula 26 4 29 6.42 no no no no
27 PB 35 F 81170 I TA repair 110 Tendon Rupture 26 4 29 6.4 no no no no
28 BS 50 M 81194 I Tibia Nailing 132 Fracture Left Leg 26 4 29 5.79 no no no no
29 AR 55 M 81141 I LTFMH 110 Inguinal Hernia 26 4 29 5.8 no no no no
30 MS 40 M 80008 I PFN Left 128 Fracture Femur 26 4 29 5.84 no no no no
11
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 75 73 82 71 80 73 75 80 73 73 80 75 78 80 73 90 114 129 130 125 124 123 112 114 110 112 116 114 110 112 116 72
2 93 72 88 69 87 89 120 87 89 91 90 82 90 90 93 85 126 120 128 130 120 129 126 124 122 124 120 122 124 120 124 92
3 81 67 76 91 90 87 81 90 87 87 79 81 80 79 87 75 104 125 116 121 112 107 104 106 108 110 112 120 122 126 120 86
4 73 68 71 71 69 73 73 69 73 73 79 73 75 79 73 80 116 131 124 129 126 121 110 112 110 106 108 108 110 114 110 72
5 79 69 73 81 89 73 79 89 73 73 86 79 85 86 75 88 120 110 130 120 118 129 124 122 124 120 124 120 124 128 124 74
6 77 64 70 81 80 77 77 80 77 77 69 90 80 69 76 95 124 120 122 130 120 133 124 120 122 118 122 112 110 106 102 75
7 99 74 77 97 85 97 99 85 97 97 91 99 88 91 98 90 118 120 120 132 136 129 120 118 120 122 120 118 114 110 114 97
8 97 70 69 73 70 99 97 70 99 99 95 97 97 95 99 80 126 139 130 120 130 131 126 122 118 130 126 122 124 126 122 98
9 81 66 70 78 65 78 73 65 78 79 85 95 88 85 78 85 136 127 128 130 120 145 136 182 130 126 124 126 122 120 124 77
10 71 72 69 69 80 71 69 80 71 73 70 90 80 70 79 82 108 127 122 125 114 115 104 110 106 110 116 118 120 124 120 78
11 73 74 71 75 66 73 73 66 73 75 86 85 73 86 73 75 122 135 126 139 130 129 120 122 124 120 140 132 128 125 106 72
12 89 66 72 90 71 90 89 71 90 91 98 80 89 98 90 98 124 130 120 118 126 127 124 126 122 126 122 126 132 126 122 89
13 87 65 69 88 73 88 88 73 88 81 60 87 88 60 88 80 130 128 130 120 130 141 132 130 132 130 128 124 124 122 128 87
14 88 82 81 91 85 89 93 85 89 95 99 90 82 99 91 75 122 110 120 130 134 127 134 120 124 120 124 125 128 124 120 90
15 89 94 91 93 89 95 97 89 95 97 93 85 90 93 93 85 120 131 124 121 120 113 110 114 130 130 120 130 130 120 130 92
16 79 64 65 77 80 77 77 80 77 77 89 79 92 89 77 75 124 110 110 120 126 125 112 110 106 110 112 118 116 112 125 76
17 69 75 70 71 90 71 71 90 71 71 70 85 78 70 71 90 108 121 122 125 118 113 104 108 132 128 118 128 138 140 135 70
18 73 85 67 65 69 63 66 69 63 69 79 85 90 79 71 85 134 130 120 130 128 141 110 135 132 128 126 130 130 122 130 70
19 68 75 71 67 77 69 67 77 69 67 81 90 92 81 67 96 118 131 130 125 124 119 110 114 128 138 138 120 128 130 138 66
12
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 93 75 75 97 90 97 97 90 97 97 98 85 78 98 97 84 110 133 126 129 120 121 110 112 130 130 130 138 140 120 130 96
21 91 75 68 96 99 98 95 99 98 91 81 91 90 81 96 82 114 129 124 127 118 117 112 110 138 138 128 140 130 138 134 95
22 79 71 76 81 78 79 81 78 79 81 79 90 81 79 81 75 110 131 124 129 120 113 104 108 110 114 110 116 120 125 120 80
23 79 64 73 83 79 85 83 79 85 83 80 82 83 80 83 74 126 128 140 120 134 129 120 122 124 126 122 124 132 122 125 82
24 77 72 73 79 69 79 79 69 79 79 80 85 88 80 79 82 132 120 120 130 142 143 132 130 132 128 130 128 118 136 141 78
25 68 85 69 70 101 70 73 101 70 73 70 78 82 70 70 75 140 120 117 110 142 137 134 136 134 130 126 122 116 112 110 69
26 98 71 75 95 90 95 98 90 95 99 95 82 90 95 95 95 102 117 118 123 122 123 120 112 116 110 114 112 111 130 120 94
27 83 72 80 85 81 89 85 81 89 85 68 88 90 68 85 70 118 131 124 129 120 121 112 114 136 130 138 138 128 125 125 84
28 77 66 77 79 88 79 79 88 79 79 77 80 82 77 79 85 112 127 130 127 120 113 104 108 140 122 140 130 130 130 130 78
29 76 73 71 81 73 79 79 73 79 79 90 75 85 90 81 96 114 133 126 125 118 111 110 106 130 130 128 122 138 110 140 80
30 85 104 113 89 111 89 90 111 89 89 93 80 90 93 89 94 130 120 120 120 120 141 130 128 130 132 130 134 120 134 132 88
13
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 72 84 72 83 71 77 70 70 72 70 70 72 80 70 92 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
2 84 78 78 80 83 78 82 82 80 80 84 80 80 82 80 80 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
3 70 82 76 75 65 69 68 64 66 64 70 84 76 80 74 80 100 99 99 99 100 100 100 100 100 100 100 100 100 100 100 100
4 76 80 78 83 69 77 72 70 68 60 72 68 82 75 76 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
5 84 80 70 85 85 82 80 80 80 82 80 74 80 84 82 80 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
6 80 72 80 87 81 85 82 82 74 74 80 80 76 66 64 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
7 72 78 78 89 83 82 76 70 84 84 84 70 90 66 82 80 100 100 100 100 99 100 100 100 100 100 100 100 100 99 100 100
8 82 80 78 84 77 87 84 86 74 82 78 80 80 84 80 66 100 100 100 100 100 100 100 100 100 100 100 100 100 100 98 100
9 94 80 72 85 89 80 90 84 86 84 80 84 76 82 80 84 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
10 74 82 82 81 88 75 66 84 74 66 70 76 82 80 84 80 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
11 78 84 72 78 85 78 84 76 80 82 74 60 72 64 76 76 99 100 99 100 100 100 100 100 100 100 100 100 100 100 100 100
12 80 84 70 80 67 68 80 82 82 88 80 74 84 90 84 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 99 100
13 84 72 72 82 93 82 90 86 90 92 88 80 82 92 88 76 100 100 100 99 100 100 100 100 100 100 100 100 100 100 100 100
14 86 85 70 84 81 87 80 78 80 74 81 84 86 80 78 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
15 76 82 78 75 86 69 72 68 72 70 78 72 86 95 74 80 100 100 100 100 100 98 99 99 100 100 99 100 100 100 100 100
16 72 80 72 89 76 73 70 66 85 66 74 74 90 80 88 82 100 100 100 100 100 100 100 100 98 99 100 98 99 99 100 100
17 64 74 82 83 73 67 66 70 80 62 85 88 72 68 64 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
18 90 80 74 82 89 88 96 92 90 89 86 80 84 88 80 76 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
19 80 84 78 80 73 81 72 72 74 70 70 72 72 85 62 80 99 100 100 100 100 100 100 100 100 100 100 100 100 100 98 100
14
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 74 76 72 81 86 75 68 70 76 68 72 70 82 82 92 75 100 100 99 100 99 100 100 100 100 100 100 100 100 100 100 100
21 70 74 78 85 63 69 70 68 74 72 88 92 66 60 64 68 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
22 72 80 78 78 67 65 66 76 85 70 78 80 62 70 72 88 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
23 84 72 80 75 81 80 82 84 80 84 84 80 88 84 80 70 100 99 100 99 100 100 100 100 100 100 100 100 100 99 100 98
24 86 80 82 72 85 93 86 94 86 86 98 82 86 92 96 66 100 100 100 100 100 100 99 99 100 99 99 100 99 100 98 100
25 92 85 72 80 87 80 90 90 88 92 80 76 92 85 88 82 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
26 64 76 82 75 86 79 74 70 85 75 80 87 70 70 72 78 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
27 76 86 72 77 76 75 66 72 74 85 74 68 72 70 68 82 98 100 99 100 100 100 100 100 100 100 100 100 100 100 100 100
28 70 82 82 79 88 71 68 66 74 68 75 64 66 74 74 70 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
29 72 80 82 76 73 85 85 64 64 65 88 82 74 68 70 74 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
30 96 82 72 74 87 97 92 90 92 90 86 96 92 90 94 82 100 100 100 100 100 100 100 100 90 100 100 90 100 100 100 100
15
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 4 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 1 3 1 1 1 1 1 3 1 1 1 1 1 1 1
2 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 1 2
3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
4 4 3 3 4 4 4 4 4 4 4 4 3 3 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
5 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 3 2 1 2 2 1 2 2 2 2 3 1 2 1
6 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 1 2 1 3 2 1 2 2 1 1 1 2 2 2 2
7 4 4 4 4 3 3 4 4 4 4 4 4 4 3 4 4 2 2 2 2 2 1 2 2 1 2 2 2 2 2 2 2
8 4 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
9 4 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 1 2 2 2 2 1 2 2 1 2 2 2 2 2
10 4 4 4 4 4 4 4 4 4 3 3 4 4 4 4 4 1 3 2 1 2 2 2 2 2 2 2 2 1 1 2 1
11 4 4 4 4 4 4 4 3 3 3 4 4 4 4 4 4 2 2 2 2 3 2 1 2 2 3 2 2 2 2 2 2
12 4 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 2 2 2 3 2 1 2 3 3 2 2 2 2 2 2 2
13 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 1 2 2 2 2 2 2 2 3 1 3 2 2 2
14 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 2 2 2 2 2 3 2 2
15 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 3 2 2 2 2 3 2 2 2 2 2 2 2 2 2
16 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 3 2 3 3 2 2 2 2 2 2 1 3
17 4 4 4 4 4 4 3 3 4 4 4 4 4 4 4 4 2 2 1 2 2 2 2 2 1 1 2 2 3 2 2 2
18 4 4 4 4 4 3 3 4 4 4 4 4 4 4 4 4 2 2 2 3 2 3 2 2 2 2 2 2 2 3 2 2
19 4 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 1 1 3 2 2 2 2 2 2 2 2 3 2 2 2 2
16
GROUP B (CLONIDINE)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 3 2 2 2 2 2 2 3 2 2 2 2 3
21 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 1 2 2 3 2 3 2 2 1 2 2 2
22 4 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 2 2 2 2 3 2 2 2 2 3 3 2
23 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 2 2 3 2 2 2 2 2 2 2 2 2 2 2 2
24 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 3 3 2 2 3 2 3 2 2 2 3 2 2 2 2
25 4 4 4 4 4 4 4 4 4 4 4 3 4 4 4 3 2 2 2 2 3 2 2 2 2 2 2 2 3 2 2 2
26 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 1 2 3 2 2 3 2 2 2 3 2 2 2 2 3
27 4 4 4 4 4 4 4 4 4 4 4 3 3 4 4 4 1 2 2 2 2 2 2 2 1 1 2 2 2 3 3 2
28 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 2 2 2 2 1 2 2 2 2 2 2 3 1 2 2 2
29 4 4 4 3 4 4 4 3 3 3 4 4 4 4 4 4 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2
30 4 4 4 3 4 4 4 3 3 3 4 4 4 4 4 4 2 3 1 3 2 1 2 2 1 2 3 2 2 3 3 3
17
GROUP C (DEXMEDETOMIDINE)
Time from drug administration to control of shivering
Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

1 GS 56 M 84399 I DFLP 120 Fracture Femur 26 4 29 2.68 yes no no yes

2 SS 40 M 3223 I Prostectomy 112 BPH 26 4 29 2.7 no no no no
3 BS 22 M 88553 I Appendicectomy 120 Appendicitis 25 4 29 2.72 yes no no no
4 BS 50 M 1661 I TKR Left side 113 Bilateral Osteoarthitis 26 4 29 2.8 no no yes no
5 SS 29 M 84415 I External fixator 110 Fracture Femur 26 4 29 2.9 no no no no
6 JS 55 M 1738 I External fixator 140 Fracture Femur 25 4 29 2.92 no yes no yes
7 SS 55 M 83673 I Tibia Plating 130 Fracture Left Leg 25 4 29 2.87 yes no no no
8 SS 46 M 84791 I DHS 120 Fracture Femur 26 4 29 2.77 no yes no no
9 MS 38 M 2582 I Fistulectomy 110 Fistula in Ano 26 4 29 2.78 no no no no
10 SK 32 M 2520 I Orchidectomy 120 Ectopic testis 26 4 29 2.69 no no no no
11 KS 44 M 93190 I Debridement 110 Fourniers gangrene 26 4 29 2.7 no yes no no
12 AS 50 M 85649 I TKR Left side 120 Osteoarthitis knee 26 4 30 2.72 yes no no no
13 Name 43 F 85621 I Flexi Nail Fixation 110 Fracture Femur 26 4 29 2.74 no no no no
14 AR 50 F 85638 II RC Plating 120 Fracture pelvis 26 4 29 2.8 no no no no
15 JS 56 M 85633 I Implant Removal 110 Fracture Tibia 26 4 29 2.9 no yes no no
16 JK 35 F 85629 II Implant Removal 110 Fracture Tibia 26 4 29 2.92 yes yes no no
17 KS 50 M 84993 I ORIF with NDCP 132 Fracture Femur 26 4 29 2.82 no no no no
18 R 50 M 85452 I ILN Tibia 120 Fracture Tibia 26 4 29 2.84 no no no no
19 SS 40 M 81392 II TBW Patella 120 Fracture patella 26 4 29 2.86 no yes no no
18
GROUP C (DEXMEDETOMIDINE)
Time from drug administration to control of shivering
Time for onset of shivering (minutes)

Temp at onset of shivering (°C)

Post drug nausea and vomiting

Duration of surgery (minutes)

Recurrence of shivering
Operative procedure

Grades of shivering

Hypotension
Bradycardia
ASA grade

Diagnosis

(minutes)
CR No.
Sr. No.

Name

Age

Sex

20 DS 40 M 1412 I ORIF with plating 120 Fracture Tibia 26 4 29 2.89 no no no no

21 AK 45 F 2102 I ILN Tibia 120 Fracture Tibia 26 4 29 2.92 yes no no no
22 TS 30 M 81231 I ILN Tibia 110 Fracture Tibia 26 3 29 2.89 no yes no no
23 J 25 M 2107 II ILN femur 120 Fracture Femur 26 4 29 2.86 no yes no no
24 GS 50 M 85806 I External fixator tibia 120 Fracture Tibia 26 4 29 2.89 no no no no
25 GS 48 M 131 I Circumcision 60 Phimosis 25 4 29 2.74 no yes no no
26 JS 43 M 100131 I Secondary Resuturing 100 Burst abdomen 24 4 30 2.76 no no no no
27 KS 56 M 84399 II DFLP Fixation 120 Fracture Femur 25 4 30 2.75 no yes no no
28 AS 40 M 1927 I Stripping and ligation 116 Varicose Vein 22 4 29 2.7 no no no no
29 AS 26 M 85484 I Implant Readjustment 124 Fracture Tibia 26 4 29 2.77 no yes no no
30 HN 32 M 81221 II K wire fixation 128 Fracture Calcaneum 27 4 29 2.78 no no no no
19
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 74 75 85 74 85 72 74 79 72 85 81 74 74 80 73 81 121 108 117 123 130 123 124 124 124 118 120 125 125 125 120 118
2 80 74 91 72 90 88 119 86 88 92 91 92 119 89 92 87 115 120 115 124 130 122 74 118 119 119 140 120 119 117 122 119
3 80 69 79 94 85 86 80 89 86 88 80 80 80 78 86 88 140 133 137 140 139 137 143 142 140 135 141 141 144 141 140 135
4 72 70 74 74 75 72 72 68 72 85 80 72 72 85 74 87 129 104 130 138 125 130 132 128 129 128 130 130 133 128 133 128
5 78 71 76 84 88 72 78 88 72 74 87 78 78 80 75 84 126 131 125 120 120 127 129 118 124 125 130 125 130 128 128 125
6 76 66 73 84 79 76 76 79 76 78 90 76 76 85 72 79 123 127 132 129 138 133 126 114 122 131 124 123 127 126 135 131
7 82 76 80 100 84 96 98 84 96 98 92 98 98 90 97 78 151 131 157 154 130 155 154 154 150 153 140 151 120 128 140 153
8 90 72 72 76 72 98 96 69 98 92 96 96 96 94 98 73 131 138 137 128 120 135 134 134 126 135 120 127 128 135 130 135
9 80 68 73 81 82 77 72 64 77 80 95 80 72 84 77 69 121 130 121 123 119 122 116 123 119 117 140 120 119 123 124 117
10 78 74 72 72 79 70 68 79 70 74 80 78 68 69 78 75 129 133 125 132 127 125 126 124 122 127 124 123 131 127 132 127
11 72 76 74 100 88 72 72 65 72 76 85 82 72 85 75 65 128 127 127 128 130 127 133 128 124 133 120 125 130 130 128 133
12 88 68 75 93 70 89 88 70 89 90 88 88 88 97 89 74 130 125 132 120 118 127 138 133 124 137 114 125 110 132 136 137
13 86 67 72 91 80 87 87 72 87 82 82 86 87 59 87 75 141 127 141 130 138 145 146 142 142 143 140 143 145 135 110 143
14 85 84 85 94 84 88 92 84 88 80 82 87 92 98 90 70 119 131 121 123 120 122 121 122 119 120 118 120 121 121 123 120
15 88 96 94 96 88 94 96 88 94 98 88 88 96 92 92 88 129 139 131 128 120 125 124 132 122 125 110 123 133 131 128 125
16 78 66 68 80 79 76 76 79 76 78 85 78 76 88 76 87 111 128 115 118 130 117 116 118 114 115 114 115 115 113 118 115
17 85 72 73 74 89 70 70 89 70 95 90 82 70 90 75 84 129 111 131 136 118 135 126 132 132 124 120 133 131 131 136 124
18 72 64 70 68 84 62 65 68 62 90 85 72 65 80 72 73 139 121 143 128 130 143 142 138 140 139 132 141 145 143 146 139
19 80 66 80 70 95 68 66 76 68 92 80 88 66 75 64 85 107 111 109 117 120 115 116 108 116 115 130 117 116 109 112 115
20
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
Heart rate (per minute) SBP (mmHg)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 88 77 72 98 92 96 96 89 96 98 75 92 96 97 96 78 127 123 129 135 118 134 136 130 131 133 120 132 127 129 136 133
21 90 67 71 99 92 97 94 98 97 85 82 90 94 80 95 76 141 135 145 147 120 143 146 152 140 145 118 141 149 143 130 145
22 78 73 85 84 85 78 80 77 78 82 82 78 80 78 80 86 113 101 123 121 135 121 120 116 122 123 120 123 125 121 126 123
23 78 66 76 86 80 84 82 78 84 98 80 78 82 79 82 69 119 127 121 125 118 125 126 122 122 123 130 123 125 121 126 123
24 76 74 80 82 75 78 78 68 78 80 85 76 78 79 78 77 101 121 109 107 128 119 116 114 112 113 120 113 117 115 118 113
25 88 71 72 73 90 69 85 100 69 80 80 82 72 75 72 90 105 121 117 115 130 121 108 110 118 119 140 119 111 107 112 119
26 97 73 95 86 88 94 97 89 94 82 74 97 87 90 90 88 111 137 113 117 130 117 114 114 114 115 130 115 117 113 118 115
27 82 80 83 82 90 88 84 80 88 76 88 82 84 82 84 90 149 141 155 159 138 155 154 154 152 151 148 153 157 153 140 151
28 88 68 80 85 82 78 78 82 78 80 82 76 78 76 78 98 141 127 145 141 130 145 146 146 149 142 118 150 147 143 154 142
29 75 75 74 87 82 78 78 72 78 80 89 75 78 89 88 90 111 125 115 119 124 119 116 116 120 116 114 121 115 113 120 116
30 84 106 98 92 90 88 89 110 80 78 85 84 89 92 88 98 109 120 113 109 122 109 104 111 114 104 136 115 113 111 110 104
21
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 69 72 77 73 85 69 69 67 75 75 85 71 92 73 69 75 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
2 77 84 77 95 79 78 95 78 77 81 82 79 78 95 80 81 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
3 81 84 83 81 81 81 81 89 83 83 85 83 81 81 87 83 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
4 81 76 73 76 81 96 109 101 77 77 78 107 82 76 100 77 100 99 100 100 99 100 100 100 100 100 100 100 100 100 100 100
5 81 78 63 81 81 81 81 90 79 79 80 83 81 81 87 79 100 100 100 100 100 100 100 100 100 100 100 100 100 100 99 100
6 89 80 63 78 82 89 89 88 77 77 72 87 89 78 89 77 100 100 100 100 100 100 100 100 100 100 99 100 100 98 100 100
7 91 90 79 97 80 91 91 93 99 99 80 93 88 97 95 99 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
8 79 82 73 99 85 79 79 78 97 97 82 81 79 99 79 97 100 100 99 100 100 100 99 100 100 100 100 99 100 100 100 100
9 68 88 69 73 80 67 65 66 71 66 78 65 61 73 68 66 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
10 67 64 73 68 82 71 68 68 68 69 80 68 87 68 69 69 99 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
11 71 74 83 73 84 61 71 73 71 69 85 71 71 73 71 69 100 100 100 99 100 99 100 100 100 99 100 100 100 100 98 100
12 63 76 78 64 80 70 64 64 64 61 85 64 82 64 65 61 100 100 100 100 100 100 100 99 100 100 100 100 100 100 100 100
13 89 84 77 85 87 91 85 90 89 81 84 76 89 85 83 81 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
14 71 82 80 69 80 69 71 69 71 91 85 71 71 69 69 91 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
15 69 80 83 78 78 77 71 73 77 86 80 73 92 78 78 86 100 99 100 100 100 100 100 100 100 99 99 100 99 100 100 100
16 79 78 74 81 84 77 81 81 81 91 80 88 80 81 81 91 100 100 100 100 100 100 100 100 100 100 100 98 100 100 100 100
17 85 70 67 81 85 81 83 89 89 83 85 83 81 81 76 83 100 100 100 100 100 100 100 100 99 100 100 100 100 100 100 100
18 81 86 65 79 89 88 85 89 79 89 80 85 90 79 79 89 100 100 100 100 99 100 100 100 100 100 100 100 100 100 100 100
19 61 87 80 68 80 69 79 68 68 76 85 79 69 68 68 76 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
22
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
DBP (mmHg) SPO2 (%)
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 79 80 69 81 72 75 87 81 81 75 78 81 82 81 83 75 100 100 99 100 100 99 100 100 100 100 100 100 100 100 100 100
21 89 76 71 83 89 78 81 81 81 88 80 83 81 83 89 88 100 100 100 100 100 100 100 100 100 100 100 100 100 100 99 100
22 69 70 71 71 78 66 73 71 71 66 78 73 71 86 71 66 100 100 100 100 100 100 100 100 100 100 100 100 100 99 100 100
23 73 70 73 75 88 75 71 75 75 75 82 71 75 75 75 75 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
24 77 64 85 81 85 75 73 79 76 76 82 83 77 81 79 76 100 100 100 100 100 100 99 100 100 100 99 100 100 100 100 100
25 63 70 78 65 80 69 67 65 65 76 78 88 85 65 65 76 99 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
26 69 78 81 67 86 69 69 69 67 69 88 65 69 67 69 69 100 100 100 100 100 100 100 100 100 99 100 100 100 100 100 100
27 91 90 93 89 89 72 89 93 86 89 78 76 89 89 76 89 100 99 100 100 100 100 100 99 100 100 100 100 100 100 100 100
28 81 70 79 85 72 77 81 83 61 77 80 81 79 85 81 77 100 100 100 100 99 100 100 100 100 100 100 100 100 100 100 100
29 71 76 72 73 78 71 73 71 73 71 82 73 69 73 73 71 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100 100
30 77 70 73 78 82 75 78 80 79 75 82 78 75 81 79 75 100 100 100 100 100 100 99 100 100 100 100 98 99 100 100 100
23
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
1 3 4 4 4 3 4 4 4 4 4 4 4 4 4 4 4 3 4 3 4 3 4 3 3 4 3 4 3 4 4 3 4
2 3 4 4 4 3 4 4 4 4 4 4 4 4 4 4 4 3 3 4 3 3 3 3 3 3 3 3 3 3 3 3 3
3 3 4 4 4 3 4 4 4 3 4 4 3 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
4 3 4 4 4 3 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
5 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 3 4 4 3 4 4 3 4 4 4 4 3
6 4 4 4 4 4 4 4 4 4 3 4 4 3 3 4 4 4 4 3 4 4 3 3 4 3 3 4 3 3 3 3 3
7 4 4 4 4 4 4 4 4 3 4 4 4 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4
8 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 3 4 3 3 3 3 3 3 3 3 3 3 3 3 3
9 4 4 4 4 3 4 4 4 4 3 4 4 4 4 4 4 3 3 3 4 3 4 3 3 3 3 3 4 3 3 3 3
10 4 4 4 4 3 4 4 4 3 4 4 4 4 4 3 4 3 3 3 3 4 3 4 3 4 4 3 3 4 4 3 3
11 4 4 4 4 4 4 4 4 4 4 4 3 3 4 4 4 3 3 3 3 3 3 3 3 3 3 4 3 3 3 4 4
12 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 3 4 3 3 3 3 3 3 3 3
13 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 4 3 3 3 3
14 3 4 4 4 4 4 4 4 4 4 3 3 4 4 4 4 3 3 4 3 4 3 3 3 3 3 3 3 3 4 3 3
15 4 4 4 4 4 4 4 4 4 4 4 3 3 3 4 4 3 3 3 4 3 4 4 3 4 3 4 3 4 3 3 4
16 3 3 3 4 4 4 4 4 4 3 4 3 3 4 4 4 3 3 3 3 3 3 3 4 3 4 3 3 3 3 4 3
17 3 3 3 4 4 4 4 4 3 4 4 4 4 4 3 4 4 3 3 3 3 3 3 3 3 3 3 4 3 3 3 3
18 4 3 3 4 4 3 4 4 4 4 4 4 3 3 3 4 3 3 3 4 4 3 3 3 3 3 3 3 3 4 3 3
19 4 3 4 4 4 3 3 4 4 4 4 3 4 3 3 3 3 4 3 3 3 4 3 3 3 3 4 3 4 3 3 3
24
GROUP C (DEXMEDETOMIDINE)
HEMODYNAMIC PARAMETERS
Shivering grade Sedation scale
Baseline

Baseline
105 min

120 min

105 min

120 min
Sr. No.

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min

10 min

15 min

20 min

25 min

30 min

45 min

60 min

75 min

90 min
2 min

4 min

6 min

8 min

2 min

4 min

6 min

8 min
20 4 3 4 3 4 3 3 4 4 4 4 4 4 4 4 4 3 3 4 3 3 3 4 3 3 4 3 4 3 3 4 4
21 4 3 3 3 4 3 3 4 4 4 4 4 4 4 4 4 3 3 3 3 3 3 3 4 4 3 3 3 3 3 3 3
22 4 3 3 3 4 3 3 4 4 4 4 4 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 3 3 4 3 3
23 4 4 4 4 4 3 4 4 4 4 3 4 4 4 3 4 4 3 3 4 4 3 3 3 3 3 4 3 4 3 3 3
24 4 4 4 4 4 3 4 4 4 4 4 4 4 4 3 4 3 3 4 3 3 3 3 3 3 3 3 4 3 3 3 4
25 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 4 3 3 3 3 3 3 3 4 3 3 3 3 4 3
26 4 4 4 4 4 4 3 3 4 3 4 4 4 4 4 4 3 3 3 3 4 4 4 3 3 3 4 3 3 4 3 3
27 4 4 4 4 4 4 4 4 4 3 4 4 4 4 4 4 3 3 3 4 3 3 3 4 4 3 3 3 4 3 3 4
28 4 4 4 4 4 4 4 4 4 3 4 4 4 4 4 4 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3
29 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 3 4 3 4 3 3 3 3 3 3 3 3 3 3 3 4 4
30 4 4 4 4 4 4 4 4 4 4 3 4 4 4 4 3 3 4 3 4 4 4 3 3 3 4 4 3 4 3 3 3
 COMPARATIVE STUDY OF
DEXMEDETOMIDINE, CLONIDINE AND
TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY
UNDER SPINAL ANAESTHESIA

THESIS PROPOSAL
FOR APPROVAL OF SUBJECT OF THESIS
TO BE SUBMITTED
IN PARTIAL FULFILMENT OF REQUIREMENT
FOR THE DEGREE OF
M.D (ANAESTHESIOLOGY)
BABA FARID UNIVERSITY OF HEALTH SCIENCES
FARIDKOT

2021 DR. DIPAK SINGH

DEPARTMENT OF ANAESTHESIOLOGY & INTENSIVE CARE

GOVT. MEDICAL COLLEGE, AMRITSAR
 BABA FARID UNIVERSITY OF HEALTH SCIENCES, FARIDKOT
APPLICATION FORM FOR APPROVAL OF SUBJECT OF PLAN OF THESIS
FOR
M.D. (ANAESTHESIOLOGY)

1. Name of the candidate DR. DIPAK SINGH

2. Father’s name MR. RAM CHANDRA MONDAL
3. Mother’s name MRS. SUNAIYANA DEVI

Address of the candidate for Near BSNL Tower, Kelabari, Pokhariya,

4.
correspondence Sahibganj

Month and year of passing

5. M.B.B.S. examination with March, 2018
internship
Name of University from which Rajendra Institute of Medical Sciences,
6.
graduated Ranchi, Jharkhand
Post-Graduate Student in the
7. Present occupation Department of Anaesthesiology,
Government Medical College, Amritsar
8. Experience after graduation None
9. Date of joining M.D. course June, 2020

10. Likely date of appearing May/June, 2023

COMPARATIVE STUDY OF
DEXMEDETOMIDINE,
CLONIDINE AND TRAMADOL
11. Proposed subject of thesis FOR CONTROL OF POST
OPERATIVE SHIVERING
AFTER SURGERY UNDER
SPINAL ANAESTHESIA
Adequate facilities are available in the
Facilities for work on the subject Department of Anaesthesiology &
12.
of thesis Intensive Care, Government Medical
College, Amritsar
Detailed scheme according to
13. which the candidate proposes to Plan attached
work
 DR. Joginder Pal Attri
M.D.,
Professor,
Name and address of
14 Department of Anaesthesiology &
Supervisor
Intensive Care,
Government Medical College,
Amritsar
DR. Amar Parkash Kataria
M.D.,
Professor,
Name and address of
15 Department of Anaesthesiology &
Co-supervisor
Intensive Care,
Government Medical College,
Amritsar

______________________________

SIGNATURE OF THE CANDIDATE

DATED: __________
 UNDERTAKING

The topic submitted by Dr. Dipak Singh, “COMPARATIVE STUDY OF

DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR

CONTROL OF POST OPERATIVE SHIVERING AFTER SURGERY

UNDER SPINAL ANAESTHESIA” for approval has not already used by

anyone in this institution and its own topic/research.

DR. AMAR PARKASH KATARIA DR. JOGINDER PAL ATTRI

M.D., M.D.,
Professor, Professor,
Department of Anaesthesiology & Department of Anaesthesiology &
Intensive Care, Intensive Care,
Government Medical College, Government Medical College,
Amritsar Amritsar

(Co-Supervisor) (Supervisor)

DR. DIPAK SINGH

Junior Resident,
Department of Anaesthesiology and Intensive Care,
Govt. Medical College, Amritsar

DATED ……………………
PLACE: AMRITSAR
 CERTIFICATE OF SUPERVISORS

This is to certify that the facilities for work on the subject of thesis titled
“COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE
AND TRAMADOL FOR CONTROL OF POST OPERATIVE
SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA” do
exist in the Department of Anaesthesiology and Intensive Care, Govt.
Medical College, Amritsar and will be provided to the candidate. We shall see
that the data being included in the thesis is genuine and is collected by the
candidate himself under our supervision and guidance.

DR. AMAR PARKASH KATARIA DR. JOGINDER PAL ATTRI

M.D., M.D.
Professor, Professor,
Department of Anaesthesiology & Department of Anaesthesiology &
Intensive Care, Intensive Care,
Government Medical College, Government Medical College,
Amritsar Amritsar

(Co-Supervisor) (Supervisor)

Dated ……….………………
Place: Amritsar
 DEPARTMENT OF ANAESTHESIOLOGY AND INTENSIVE CARE
GOVT. MEDICAL COLLEGE, AMRITSAR

This is to certify that the facilities for work on the subject of thesis titled
“COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE
AND TRAMADOL FOR CONTROL OF POST OPERATIVE
SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA” do
exist in the Department of Anaesthesiology & Intensive Care, Govt. Medical
College, Amritsar and will be provided to the candidate. The subject of thesis
is connected with Science and Practice of Medicine.

Professor & Head,

Department of Anaesthesiology & Intensive Care,
Govt. Medical College, Amritsar

Dated ……………
Place: Amritsar
 GOVERNMENT MEDICAL COLLEGE, AMRITSAR
Name of the candidate DR. DIPAK SINGH
Department of Anaesthesiology and Intensive Care
Topic COMPARATIVE STUDY OF DEXMEDETOMIDINE,
CLONIDINE AND TRAMADOL FOR CONTROL OF
POST OPERATIVE SHIVERING AFTER SURGERY
UNDER SPINAL ANAESTHESIA
Examination MD (ANAESTHESIOLOGY)
Date of enrolment June 2020
In which Research Committee has the Thesis Research committee of Govt. Medical College,
thesis been presented and approved Amritsar
Professor and Head of Speciality Professor & Head,
Department of Anaesthesiology &
Intensive Care,
Govt. Medical College,
Amritsar
Supervisor of the thesis DR. JOGINDER PAL ATTRI. M.D.,
Professor,
Department of Anaesthesiology &
Intensive Care,
Government Medical College,
Amritsar
Co-supervisor of the thesis DR. AMAR PARKASH KATARIA, M.D.,
Professor,
Department of Anaesthesiology &
Intensive Care,
Government Medical College,
Amritsar
MEMBERS OF THE THESIS/
SIGNATURE WITH STAMP
RESEARCH COMMITTEE
1. Head of the institute/college
2. Chairman of Thesis committee
 Member thesis committee
 Member thesis committee
 Member thesis committee
3. Chairman ethical committee
 Member ethical committee
 Member ethical committee
 Member ethical committee
 ABSTRACT OF PLAN OF THESIS

COMPARATIVE STUDY OF
DEXMEDETOMIDINE, CLONIDINE AND
Title
TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY
UNDER SPINAL ANAESTHESIA
For the degree of M.D. (ANAESTHESIOLOGY)
Name of the candidate DR. DIPAK SINGH
DR. JOGINDER PAL ATTRI
M.D.,
Name of Supervisor Professor,
Deptt. of Anaesthesiology & Intensive Care,
Government Medical College, Amritsar
DR. AMAR PARKASH KATARIA,
M.D.,
Name of co-supervisor Professor,
Deptt. of Anaesthesiology & Intensive Care,
Government Medical College, Amritsar
Department of Anaesthesiology,
Institution
Govt. Medical College, Amritsar.

The aim of the present study is to compare the effect of tramadol, clonidine
and dexmedetomidine for the control of post operative shivering after surgery under
spinal anaesthesia.

In a randomized double blinded manner, 90 patients will be taken of ASA

(American Society of Anaesthesiologist) Grade I and Grade II in the age group of
18-60 years. The patient will be randomly allocated in three group with 30 patients
in each group.

Group A will receive tramadol 1 milligram /kg body weight.

Group B will receive clonidine 1 microgram/kg body weight.

Group C will receive dexmedetomidine 0.5 microgram/kg body weight.

The haemodynamic monitoring will be continued after the administration of

these drugs. Baseline pulse rate, blood pressure, respiratory rate, SpO2,
temperature, shivering grade and sedation scale will be recorded.
 INTRODUCTION

Shivering is a common post anaesthetic occurrence which is defined as

involuntary repetitive activity of skeletal muscle. It is a common and distressing
experience to many patients which occurs either during or immediately after the
surgery. The incidence of shivering following spinal anaesthesia is 30-60%.
Spinal anaesthesia is widely used as safe anaesthesia technique for both
elective and emergency operations including all open gynaecology and
obstetric surgery, orthopedic and plastic surgery of lower limb and pelvis,
general surgery of pelvis and lower abdomen and majority of urological
procedure.1

The main causes of intra operative/ post operative shivering are

temperature loss, increased sympathetic tone, pain and systemic release of
pyrogens. Shivering is potentially serious complication that occurs in 20-70% of
the surgeries in post operative period which results in increased metabolic rate,
increases oxygen consumption (upto 100-600%) along with increased carbon
dioxide production, ventilation and cardiac output. It causes arterial hypoxemia,
lactic acidosis, increased intraocular pressure and intracranial pressure which
interferes with pulse rate, blood pressure and ECG monitoring. 2

It is a physiological response to core heat production. The core body

temperature is maintained within range of 36.5-37.5o C which is known as
thermo neutral zone. Thermo regulatory response like vasoconstriction and
shivering are activated when core body temperature falls below normal range.3
The spinal α motor neurons and their axons mediate the neurological
mechanism of shivering with centre at pre-optic muscles of the anterior
hypothalamus.4

1
 After spinal anaesthesia shivering is more common than after general
anaesthesia as vasoconstriction effect after heat loss during surgery is lost
when patient in under spinal anaesthesia.

Pathogenesis: Inhibition of thermo-regulation and non thermo-regulatory

mechanism, anaesthetic induced inhibition of thermo-regulation, pain,
uncontrolled spinal reflexes and cutaneous vasodilation.5

There are many non pharmacological and pharmacological methods to

control shivering. The non pharmacological methods include use of blankets,
warming iv fluid, use of external warmer, warming of skin surface.6

The pharamacological methods include drug like tramadol, clonidine,

dexmedetomidine. Tramadol is a synthetic opioid analgesic. It has two
mechanisms of action. Inhibition of re-uptake of serotonin and nor epinephrine
and binding to µ type of opioid receptor. Its analgesic potency is about one tenth
that of morphine. Tramadol can cause analgesia, nausea, vomiting, dizziness
etc., at therapeutic doses, it has no effect on heart rate and blood pressure. It
is potent analgesic which is used for a number of post-operative patients and
also intraoperatively for analgesia of sedation or as an antishivering agent. It is
also used for treating chronic pain implications including cancer pain. Tramadol
binds weakly with µ receptors while, M1 metabolite binds strongly. The
antishivering action of tramadol is due to serotonergic and noradrenergic
receptor activity and also opioid receptor activity. Because of serotonergic and
noradrenergic receptor action, it acts by inhibiting descending spinal path way.
Side effect of tramadol are hypersensitivity, nausea and vomiting, respiratory
depression, seizures and dizziness.7

Clonidine is a centrally acting α receptors agonist. It exerts its anti-

shivering effects at three levels:- hypothalamus locus cereus and spinal cord.
At hypothalamic level it decreases thermo-regulatory threshold for
vasoconstriction and shivering because hypothalamus having high density of
α-2 adrenergic receptors and hence, effective in treating post anaesthetic

2
shivering. It also reduces spontaneous firing in locus cereus. At spinal cord, it
activates α-2 receptors and release of dynorphine, nor epinephrine and
acetylcholine. It has better efficacy and lesser adverse side effects as
compared to tramadol but there was 5-10% incidence of hypotension and
bradycardia with clonidine.8

Dexmedetomidine acts by activation of α2 adrenoceptors located in the

presynaptic terminal and inhibits the release of norepinephrine. Activation of α2
adrenoceptors in the post synaptic terminal in the CNS inhibits sympathetic
activity and can cause sedation, anxiolysis, decreases shivering along with
reduced heart rate and blood pressure. α2 receptors inhibit adenylyl cyclase
activity and result in decreased intracellular cAMP levels. This inhibition of
adenylyl cyclase activity is transduced by the inhibitory regulatory proteins Gi.
It is effective in providing good hemodynamic stability. Dexmedetomidine was
faster in control of shivering as compared to tramadol and clonidine (slowest in
control of shivering).9

Recurrence rate is lower with dexmedetomidine as compared to

tramadol and clonidine. Therefore dexmedetomidine is better than tramadol
and clonidine in control of shivering because of its faster onset and less
recurrence rate.

Since, no similar study for comparing these three drugs together has been done
in our institution. So keeping this in view, we are undertaking this study to
compare the effect of dexmedetomidine, clonidine and tramadol to control post
operative shivering after spinal anaesthesia.

3
 REVIEW OF LITERATURE

Delaunay et al (1993) showed that clonidine reduced the

thermoregulatory threshold for vasoconstriction. This suggests that it acts by
impairing central thermoregulatory control. Clonidine significantly decreased
the thermoregulatory threshold for shivering by 0.6 – 0.3° C. Similarly, the
threshold for cutaneous vasoconstriction was significantly reduced by 0.5 + 0.2°
C. Additional clonidine administration always stopped shivering, at whatever
temperature it occurred. This study confirms that clonidine administration stops
shivering and suggests that it acts by impairing central thermoregulatory
control. That an additional dose of clonidine stops shivering in subjects already
given one dose, indicates that the effect of clonidine is dose dependent.10

Tasai YC et al (2001) conducted a study both tramadol (0.5 mg/kg) and

meperidine (0.5 mg/kg) effectively treated patients with post epidural
anaesthetic shivering. However, amitriptyline at both 15 and 20 mg did not show
significant effects in the treatment of shivering.11

Mohta M et al (2009) concluded the efficacy of intravenous tramadol in

the doses of 1, 2 and 3 mg.kg−1 is comparable to that of intravenous pethidine
0.5 mg.kg−1 to prevent postanaesthetic shivering. Tramadol 2
mg.kg−1 appears to be a good choice to be administered at the time of wound
closure to provide the dual advantage of antishivering effect as well as
analgesia without significant side effects in the postoperative period.12

Bansal P et al (2011) conducted a study that butorphanol and tramadol

were more effective than clonidine in suppressing shivering. Butorphanol,
tramadol, and clonidine completely controlled rigors in 83%, 73%, and 53% of
cases, respectively, and incompletely suppressed rigors in 16%, 26%, and 46%
of cases, respectively. Time taken to terminate rigors was significantly higher

4
for clonidine (3.3 ± 0.9 minutes) than for butorphanol and tramadol (2.1 ± 1.0
minutes and 1.8 ± 0.5 minutes;). Butorphanol had an edge over tramadol in
controlling shivering with lower chances of recurrence, though both were
superior to clonidine for this purpose with an early onset of action. They
conclude that both these opioids control rigors better than α-2 agonists.13

Shukla et al (2011) observed that both clonidine (0.5 μg/kg) and

tramadol (0.5 mg/kg) effectively treated patients with post–spinal anaesthesia
shivering, but tramadol took longer time to achieve complete cessation of
shivering than clonidine, the difference being statistically significant. So they
conclude that clonidine offers better thermodynamics than tramadol, with fewer
side effects. The more frequent incidence of side effects of tramadol, like
nausea, vomiting and dizziness, may limit it's use as an anti-shivering drug.14

Reddy VS et al (2011) showed that time taken from the starting of

treatment to cessation of shivering was significantly less with the tramadol
group, however, the frequency of nausea, vomiting, sedation and headache
were also significantly more in the tramadol group. They concluded that both
clonidine and tramadol control shivering. However, the response rate was
higher and time taken to control shivering was lesser with tramadol, but the
response rate and the side effects were lesser with clonidine.15

Usta et al (2011) conducted a study on dexmedetomidine infusion for the

prevention of shivering during spinal anesthesia. They reported that
dexmedetomidine infusion of 0.4 µg/kg/h was effective in preventing shivering
and providing sedation for minor surgical procedure. The sedation achieved
was better in dexmedetomidine than clonidine and tramadol.16

Bozgeyik et al (2014) performed a study on increasing the effect of

preemptive tramadol and dexmedetomidine in shivering during arthroscopy.
They observed in addition to its effectiveness in preventing shivering,
dexmedetomidine was superior in increases level of sedation to prevent
sedation without side effects.17

5
 Mital et al (2014) performed study on comprision of dexmedetomidine
tramadol for post spinal anesthesia shivering. They concluded
dexmedetomidine in a dose of 0.5µg/kg has faster onset to control shivering in
2.5±0.44min.18

A study done by Panneer M et al (2017) showed that dexmedetomidine

0.5 μg/kg is more efficient than clonidine 1 μg/kg in controlling postspinal
blockade shivering. Dexmedetomidine has early onset of effect, high response
rate, and less recurrence rate with added advantage of good sedation and
stable cardiorespiratory parameters.19

Kundra TS et al (2017) conducted a study on the patients who received

dexmedetomidine as well as tramadol had cessation of shivering. The time to
cessation of shivering was significantly less with dexmedetomidine (174.12 ±
14.366 s) than with tramadol (277.06 ± 23.374 s). The recurrence rate of
shivering with dexmedetomidine was less (6%) as compared to tramadol (16%).
Nausea and vomiting was found to be higher in the case of tramadol. On the
other hand, dexmedetomidine caused moderate sedation from which the
patient could be easily awoken up. They observed that dexmedetomidine offers
better results than tramadol with fewer side effects.20

Verma A et al (2018) conducted a study and showed that 98.48% of

patients shivering ceased after administration of dexmedetomidine, where as
success rate was 86.67% in tramadol group. There was early response as well
as less recurrence of shivering in dexmedetomidine group. Nausea and
vomiting occurred significantly more in tramadol group. There was no significant
haemodynamic instability in any group. Dexmedetomidine when used at a dose
of 0.5 µg/kg IV is more effective and rapid than tramadol used at a dose of 0.5
mg/kg IV to treat shivering as developed after spinal anaesthesia without any
increased side effects as well as inducing a comfortable sedation for the
patient.21

6
 Venkatraman R et al (2018) conducted a study on dexmedetomidine was
faster in the control of shivering in 5.7 ± 0.79 minutes (min) whereas tramadol
took 6.76 ± 0.93 min and clonidine was slower with 9.43 ± 0.93 min. The
recurrence rate was much lower in the dexmedetomidine group with 3.3% than
for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with
dexmedetomidine was better than clonidine and tramadol. The tramadol group
had more cases of vomiting (four) and dexmedetomidine group had six cases
of hypotension and two cases of bradycardia. Two of the clonidine patients
encountered bradycardia and hypotension. Dexmedetomidine is better than
tramadol and clonidine in the control of shivering because of its faster onset
and less recurrence rate. Though complications are encountered in the
dexmedetomidine group, they are treatable.22

7
 AIMS AND OBJECTIVES

Primary objective:-

 To study the effect of tramadol, clonidine and dexmedetomidine on post

operative shivering.

Secondary objective:-

 To compare the effect of tramadol, clonidine and dexmedetomidine on

haemodynamics.

 To compare the adverse effect among all three.

8
 MATERIAL AND METHOD

STUDY DESIGN:-

It is a prospective randomized observational clinical study to be

conducted in Guru Nanak Dev Hospital attached to Government Medical
College, Amritsar after taking written informed consent in patients vernacular
language and approval from Institutional Ethics Committee (IEC). This study is
to be conducted on 90 patients, aged 18-60 years, American Society of
Anesthesiologists (ASA) Grade I and II and scheduled to undergo elective
surgeries under spinal anesthesia and developing shivering will be included in
the study. Patients with ASA III and above, cardiac, liver and renal diseases,
allergic to any of the study drugs or patient refusal and pregnant patients will
be excluded from the study.

INCLUSION CRITERIA:-

 Patient group age between 18-60 years.

 Patient in ASA Grade I and II.
 Patient undergoing elective surgery as well as emergency lower
abdominal, lower limb, orthopedic and plastic surgery under spinal
anaesthesia.

EXCLUSION CRITERIA:-

 Patient with known hypersensitivity to clonidine, dexmedetomidine and

tramadol.
 Known history of alcohol or substance abuse.
 Known history of hyperthyroidism, cardiovascular diseases,
physiological disorders, severe diabetes or autonomic neuropathy and
urinary tract infection.

9
 Patient with ASA III and above, cardiac, liver and renal diseases, allergy
to any of study drug or patient refusal and pregnant patient.
 Patient with coagulopathy, elderly (age >65 years), bradycardia (heart
rate <60/min).

STUDY GROUPS:

The patients who will develop shivering under spinal anesthesia will be
randomly divided into three groups with 30 patients in each group. Group A
patients will receive tramadol 1 mg/kg-1, Group B will receive clonidine 1
mcg/kg-1 and Group C will receive dexmedetomidine 0.5 mcg.kg-1. The group
allotment will be decided by the computer generated random envelope method.
The first anesthesiologist opens the envelope and adds the study drug in a 100
mL normal saline and hands it to the second anesthesiologist who is blinded to
the study drug. He administers the drug over 10 min and monitors the patient.

PRE-ANAESTHETIC CHECKUP

A detailed PAC will be done a day before the surgery. Details pertaining
to the patients clinical history, general physical and systemic examinations will
be taken. Assessment of patients airway will be done. Patients will be instructed
to fast for 6 hours for semisolids and solids and 2 hours for clear fluids before
surgery.

INFORMED CONSENT

Informed consent will be taken from the patients after explaining

technique and its complications in patient’s vernacular language.

INVESTIGATIONS:-

 Electrocardiogram

 Haemoglobin

10
 Total Leucocytes Count

 Differential Leucocytes Count

 Bleeding time

 Clotting Time

 Renal Function Test

 Liver Function Test

 Viral Markers

MATERIAL REQUIRED:

 Intravenous cannula

 Infusion Set

 Ringer lactate / Normal Saline bottles

 Sponge holding forceps

 Sterile Draping sheet

 Gauze pieces

 Disposable Syringes

 Povidine Iodine Solution

 Sterile gloves

 Spinal Needle 23G

 Inj. Bupivacaine 0.5% hyperbaric 4ml ampoule

11
TECHNIQUE

On the day of surgery, all the vitals will be recorded preoperatively. After shifting
the patient, multiparameter will be attached to patients and continuous
monitoring of pulse rate, blood pressure, respiratory rate, SpO2 and axillary
temperature will be done. After venous cannulation, patient with the preloaded
with ringer lactate solution. Under all aseptic condition, patient will be asked to
lie in left lateral position. Back of the patient will be painted with betadine and
draped. Intervertebral space palpated. 23G spinal needle will be inserted into
L3-L4 space. 0.5 % of 2.2ml heavy bupivacaine will be injected into
subarachnoid space. Patient immediately will be turned to supine position.
Oxygenation will be started via simple oxygen mask. Surgery will be allowed to
proceed under obtaining adequate level of anaesthesia.

The operating room temperature will be maintained at 22 °C for all the

surgeries. No external warming devices will be used and fluids will be
administered at room temperature to all patients. The patient who develop
shivering under spinal anesthesia will be randomly divided into three groups
with 30 patients in each group. Group A patients will receive tramadol 1 mg/kg1,
Group B will receive clonidine 1 mcg/kg-1 and Group C will receive
dexmedetomidine 0.5 mcg.kg-1.

The shivering intensity will be graded on a scale of 1-4 as per Wrench.

Grade 1: Patients having one or more of the following: piloerection,

peripheral vasoconstriction, peripheral cyanosis, but without
visible muscle activity.

Grade 2: Visible muscle activity confined to one muscle group.

Grade 3: Visible muscle activity in more than one muscle group.

12
Grade 4: Gross muscle activity involving the whole body. The patients were
included in the study when they develop shivering with at least a
Grade of 2.

The hemodynamic monitoring will be continued after the administration

of study drugs. The time taken to control shivering, recurrence and adverse
effects like nausea, vomiting, dry mouth and sedation score will be observed.
The sedation score proposed by Filos et al will be followed.

Grade 1: Awake and alert patient.

Grade 2: Drowsy patient responding to verbal stimuli.

Grade 3: Drowsy but arousable to physical stimuli and

Grade 4: Unarousable patient.

The monitoring will be continued for two hours after the administration of
spinal anesthesia.

Statistical Analysis:- After taking into consideration the view of

statisticians and the monitoring parameters of the study i.e. heart rate, non
invasive blood pressure, oxygen saturation, respiratory rate, shivering intensity
scale, sedation scale and adverse effects of the study drugs etc. and to make
the power of study more than 90 %. This study will be done in 90 patients
randomly divided into 3 groups of 30 each.

The data from the present study will be systematically collected,

compiled and statistically analysed to draw relevant conclusions. The above
mentioned parameters and patients characteristics will be compared using
appropriate statistical tests.

13
 BIBLIOGRAPHY

1. Ozaki M, Kurz A, Sessler DI, Lenhardt R, Schroeder M, Moayeri A,

Noyes KM, Rotheneder E. Thermoregulatory thresholds during epidural
and spinal anesthesia. Anesthesiology: J Am Soc Anesthesiol.
1994;81(2):282-8.

2. Bhatnagar S, Saxena A, Kannan TR, Punj J, Panigrahi M, Mishra S.

Tramadol for postoperative shivering: A double blind comparison with
Pethedine. Anaesth Intensive Care. 2001;29:149–54

3. Henneman E. Organization of the motoneuron pool: the size principle.

In: Mountcastle VB, editor. Medical physiology. 14th ed. St Louis: CV
Mosby; 1980. p. 718-41.

4. Alfonsi P. Postanaesthetic shivering: Epidemiology, pathophysiology,

and approaches to prevention and management. Drugs. 2001;61:2193–
205.

5. Kranke P, Eberhart LH, Roewer N, Tramer MR. Pharmacological

treatment of postoperative shivering: a quantitative systematic review of
randomized controlled trials. Anesthesia & Analgesia. 2002;94(2):453-
60.

6. Alfonsi P. Postanaesthetic shivering. Epidemiology, pathophysiology

and approaches to prevention and management. Minerva Anestesiolog.
2003;69(5):438-42.

7. Dhimar AA, Patel MG, Swadia VN. Tramadol for control of shivering
(comparison with pethidine). Indian J Anaesth. 2007;51(1):28-31.

8. Kundra TS, Kuthiala G, Shrivastava A, Kaur P. A comparative study on

the efficacy of dexmedetomidine and tramadol on post-spinal anesthesia
shivering. Saudi J Anaesth. 2017;11(1):2.

14
9. Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic
agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics,
and the role of peripheral mu antagonists. Anesthesiol Clin.
2011;29(4):587-605.

10. Delaunay L, Bonnet F, Liu N, Beydon L, Catoire P, Sessler DI. Clonidine

comparably decreases the thermoregulatory thresholds for
vasoconstriction and shivering in humans. J Am Soc Anesthesiol.
1993;79(3):470-4.

11. Tsai YC, Chu KS. A comparison of tramadol, amitriptyline, and

meperidine for postepidural anesthetic shivering in parturients.
Anesthesia & Analgesia. 2001;93(5):1288-92.

12. Mohta M, Kumari N, Tyagi A, Sethi AK, Agarwal D, Singh M. Tramadol

for prevention of postanaesthetic shivering: a randomised double‐blind
comparison with pethidine. Anaesthesia. 2009;64(2):141-6.

13. Bansal P, Jain G. Control of shivering with clonidine, butorphanol, and

tramadol under spinal anesthesia: a comparative study. Local and
Regional Anesthesia. 2011;4:29.

14. Shukla U, Malhotra K, Prabhakar T. A comparative study of the effect of

clonidine and tramadol on post-spinal anaesthesia shivering. Indian J
Anaesth. 2011;55(3):242.

15. Reddy VS, Chiruvella S. Clonidine versus tramadol for post spinal
shivering during caesarean section: A randomized double blind clinical
study. Journal of obstetric anaesthesia and critical care. 2011;1(1):26.

16. Usta B, Gozdemir M, Demircioglu RI, Muslu B, Sert H, Yaldiz A.

Dexmedetomidine for the prevention of shiveringduring spinal
anesthesia. Clinics. 2011;66:1187-91.

15
17. Bozgeyik S, Mizrak A, Kılıç E, Yendi F, Ugur BK. The effects of
preemptive tramadol and dexmedetomidine on shivering during
arthroscopy. Saudi J Anaesth. 2014;8(2):238.

18. Mittal G, Gupta K, Katyal S, Kaushal S. Randomised double-blind

comparative study of dexmedetomidine and tramadolfor post-spinal
anaesthesia shivering. Indian J Anaesth 2014;58:257-62.

19. Panneer M, Murugaiyan P, Rao SV. A comparative study of intravenous

dexmedetomidine and intravenous clonidine for postspinal shivering in
patients undergoing lower limb orthopedic surgeries. Anesth Essays
Res. 2017;11(1):151.

20. Kundra TS, Kuthiala G, Shrivastava A, Kaur P. A comparative study on

the efficacy of dexmedetomidine and tramadol on post-spinal anesthesia
shivering. Saudi J Anaesth. 2017;11(1):2.

21. Verma A, Bhandari D, Dhande P, Jain S, Tidke S. Comparative

Evaluation of Dexmedetomidine and Tramadol for Attenuation of Post-
Spinal Anaesthesia Shivering. J Clin Diag Res. 2018;12(6).

22. Venkatraman R, Karthik K, Pushparani A, Mahalakshmi A. A

prospective, randomized, double-blinded control study on comparison of
tramadol, clonidine and dexmedetomidine for post spinal anesthesia
shivering. Revista Brasileira de Anestesiol. 2018;68(1):42-8.

16
 PROFORMA

Sr. No.

CR. No.

Name of patient:

Age and Gender:

Weight:

ASA Grade:

Group:

Operative procedure:

Duration of surgery:

Diagnosis

Date of Operation

Pre operative temperature

Time for onset of shivering (minutes)

Grades of shivering

Temperature at onset of shivering

Time from drug administration to control of shivering (seconds)

Post drug nausea

17
Post drug vomiting

Recurrence of shivering (minutes)

Drug label

History

Chief complaint

History of presenting illness

Past history

Drug history

Family history

Menstrual history

General physical examination

Pallor Icterus

Cyanosis Clubbing

Koilonychias Lymphadenopathy

Oedema

Heart rate Respiratory rate

Blood pressure Temperature

Peripheral oxygen saturation

18
State of Nutrition: Malnutrition/ Normal/ Obesity

Psychological Status: Calm/Apprehensive/Unstable

Airway assessment: As per Mallampati grading

Local spine examination

Systemic examination

Cardiovascular System

Respiratory System

Gastrointestinal System

Central nervous System

Routine investigations

Hb (haemoglobin) Total Leucocyte Count.

Differential Leucocyte count Fasting Blood sugar

Bleeding time Clotting time

Renal function Test

Prothrombin Test

Blood urea Serum creatinine

Electrocardiography Chest X ray

19
Specific investigations, if any:

Technique- Spinal anaesthesia in L3-4 intervertebral space.

Hemodynamic parameter recordings in group A (Tramadol), B (Clonidine) and C

(Dexmedetomidine) during surgery

SBP/ Sedation
Heart DBP SPO2 Temperature Shivering scale
TIME
Rate/min (mm (%) (oC) grade
Hg)
 Baseline
 2 Minutes
 4 Minutes
 6 Minutes
 8 Minutes
 10 Minutes
 15 Minutes
 20 Minutes
 25 Minutes
 30 Minutes
 45 Minutes
 60 Minutes
 75 Minutes
 90 Minutes
 105 Minutes
 120 Minutes

Continuous ECG monitoring with the cardiac monitors will be done.

20
 CONSENT FROM PATIENTS

(To be taken in vernacular language from each subject)

I_______________________ S/O, D/O, W/O________________ understand

that there are no serious effects of any of the drugs, methods to be used in the

study “COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE AND

TRAMADOL FOR CONTROL OF POST OPERATIVE SHIVERING AFTER

SURGERY UNDER SPINAL ANAESTHESIA”. However, the possibility of any

unknown side effects of these drugs or methods has been explained to me. I

therefore voluntarily agree to participate in this study. I have been explained

that I am free to withdraw from the study at any time without any terms and

conditions.

Patient’s Name: Doctor’s Name:

Patient’s Signature: Doctor’s Signature:

Date: Date:

Witness’s Name:

Witness’s Signature:

Date:

21
 सहमति पत्र

मैं ..............................................पुत्र/पुत्री/पत्नी .............................................

तिवासी................................................................................................. इस प्रकार
अध्ययि शीर्ष क “COMPARATIVE STUDY OF DEXMEDETOMIDINE,
CLONIDINE AND TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY UNDER SPINAL
ANAESTHESIA” में भाग लेिे के तलए स्वे च्छा से सहमि हूं । मुझे उपस्थिि तितकत्सक
द्वारा मेरी सूंिुति के बारे में सूतिि तकया गया है , इस िरीके और भार्ा में तक मैं अध्ययि

के उद्दे श्य और प्रकृति, उपिार की प्रकृति, जाूं ि आति को समझिा हूं । मुझे यह भी

समझाया गया है तक डे टा गोपिीय रखा जाएगा। पहिाि प्रकट तकए तबिा केवल

शैक्षतिक उद्दे श्य के तलए उपयोग तकया जािा है । मैं इस अध्ययि में शातमल होिे के तलए
अपिी सहमति िे िा हूं । मुझे ऐसा करिे के तलए कारि तिए तबिा अध्ययि के िौराि

तकसी भी समय अध्ययि से बाहर तिकलिे के अपिे अतिकार के बारे में पिा है । मुझे

अध्ययि की प्रतिया के बारे में बिाया गया है और आवश्यकिािुसार इस में भाग लेिे के

तलए सहमि हूं ।

मुझे यह भी समझाया गया है तक प्रतिया से पहले और बाि में िस्वीरें ली जा सकिी हैं
और गोपिीय रखी जािी हैं और पहिाि का खुलासा तकए तबिा केवल शै क्षतिक उद्दे श्य
के तलए उपयोग तकया जािा है ।

रोगी का िाम / अतभभावक: डॉक्टर का िाम:

रोगी / अतभभावक का हस्ताक्षर हस्ताक्षर:

तिति: तिति:
साक्षी का िाम:
हस्ताक्षर:
तिति:

22
 wohia oiakwzdh ckow
imqI
mYN_______________________pqnI/pu`qr/p`uqrI___________________
vwsI___________________________________________________ ies

Koj “COMPARATIVE STUDY OF DEXMEDETOMIDINE,

CLONIDINE AND TRAMADOL FOR CONTROL OF POST
OPERATIVE SHIVERING AFTER SURGERY UNDER SPINAL
ANAESTHESIA”. ivc ih`sw lYx leI rjwmMd hW[ ies Koj kMm iv`c ih`sw lYx leI
mY AwpxI mrjI nwl iqAwr hW[mYN ieh d`sxw cwhuMdw /cwhuMdI hW ik ieh rzwmMdI dyx
vwsqy mYnMU iksy qrHW dw loB-lwlc nhIN id`qw igAw Aqy nW hI koeI dbwA pwieAw igAw
hY[ mYnUM ies Koj dw mnorQ smJw id`qw igAw hY Aqy mYnUM ieh Brosw idvwieAw igAw hY ik
ieh Koj ivigAwn Aqy mwnvqw dI BlweI leI hY[ mYnMU ies pRojYkt iv`c kIqy jwx vwly
tYstW dI swrI iksmw dI jWc pVqwl qy iesqymwl kIqI jwx vwlIAW swrIAW dvweIAW
dy lwB qy nukswn bwry ivsqwr pUrvk d`s id`qw igAw hY[mYnMU ies Koj kMm ivc ih`sw lYx
dw FMg qrIkw smJw id`qw igAw hY[mYnUM sUicq kIqw igAw hY ik ieh AiDAYn Akwdimk
mksd leI hY Aqy Akwdimk Aqy ivigAwink mksd leI ibmwrI dy icMnw dI Poto leI
jw skdI hY[ mYN svY ie`Cw Aqy ibnHw dbwA dy Poto lYx Aqy Akwdimk jrnl ivc Cwpx
Aqy kwnPrYNs ivc pySkrn dI sihmqI idMdw/idMdI hW [

mYN ieh Koj kMm ivc ih`sw lYx bwry Awp dI rzwmMdI iksy vI smyN vwps lY skdw hW /skdI
hW Aqy myrI rzwmMdI vwps lYx dw myry ielwj qy koeI Asr nhIN hovygw[

mrIz dw nwm: fwktr dw nwm:

mrIz dy hsqwKr: fwktr dy hsqwKr:

imqI: imqI:

gvwh dw nwm:

gvwh dy hsqwKr:

imqI:

23
 PATIENT INFORMATION SHEET

Title: “COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE

AND TRAMADOL FOR CONTROL OF POST OPERATIVE SHIVERING
AFTER SURGERY UNDER SPINAL ANAESTHESIA”.
Principal Investigator: Dr. Dipak Singh
Designation: Post Graduate student, Department of Anaesthesiology & Intensive Care,
Government Medical College, Amritsar.

Please read this form carefully. If you don’t understand the language or any
information in this sheet, please discuss with the study doctor.
Purpose of the study: “COMPARATIVE STUDY OF
DEXMEDETOMIDINE, CLONIDINE AND TRAMADOL FOR CONTROL
OF POST OPERATIVE SHIVERING AFTER SURGERY UNDER
SPINAL ANAESTHESIA”.
Information about the study: It will be an observational study approved by the
Institutional Ethics Committee, GMC, Amritsar
Patient’s role in the study:
1. To provide accurate information and cooperation during the study.
2. To allow your hospital medical records to be accessed for the purpose
of this study.
What are the potential benefits of participating in the study?
 The recommendations derived based on the outcome of this study has
the potential to change the way the physician treats the disease thereby
benefitting in further management of the patient.
What are the potential risks due to participating in the study:
 This study does not pose any significant risk to the patient.
Confidentiality: Personal data and medical records shall be used only for
research purpose and shall be kept confidential. Patients shall be identified with
the ID Number.
Voluntary participation: Entering a research study is voluntary. If patient
volunteers for a research study, he/she has the right to stop at any time.

For any queries:

Contact:
Dr. Dipak Singh
Department of Anaesthesiology & Intensive Care,
Government Medical College,
Amritsar, Punjab.
PH: +917903438297

24
 मरीज सूििा पत्र

शीर्ष क :
“COMPARATIVE STUDY OF DEXMEDETOMIDINE,
CLONIDINE AND TRAMADOL FOR CONTROL OF POST OPERATIVE
SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA”
प्रिाि अन्वेर्क: डॉ. dIpk is<h

पदनाम: पोस्ट ग्रेजुएट छात्र, एने स्थिसियोलॉजी और गहन दे खभाल सिभाग, गिनन मेंट मे सिकल कॉले ज,
अमृ तिर। कृपया इि फॉमन को ध्यान िे पढें । यसद आप इि पत्रक में भाषा या सकिी भी जानकारी को
नहीीं िमझते हैं , तो कृपया अध्ययन सिसकत्सक िे ििान करें ।

अध्ययि का उद्दे श्य: “COMPARATIVE STUDY OF DEXMEDETOMIDINE,

CLONIDINE AND TRAMADOL FOR CONTROL OF POST OPERATIVE
SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA”

अध्ययन के बारे में जानकारी: यह आिार िसमसत, जीएमिी, अमृ तिर द्वारा िर्ननात्मक अध्ययन होगा।
अध्ययि में रोगी की भूतमका:
1. अध्ययि के िौराि सटीक जािकारी और सहयोग प्रिाि करिे के तलए।
2. इस अध्ययि के उद्दे श्य से अपिे अस्पिाल के मेतडकल ररकॉडष को एक्सेस करिे की अिुमति
िे िा।
अध्ययि में भाग ले िे के सूंभातवि लाभ क्या हैं?
• इस अध्ययि के पररिाम के आिार पर प्राप्त की गई तसफाररशोूं में तितकत्सक के ibmwrI को ठीक
करिे के िरीके को बिलिे की क्षमिा है, तजससे रोगी के आगे के प्रबूं िि में लाभ होिा है ।
अध्ययि में भाग ले िे के कारि सूंभातवि जोस्खम क्या हैं :
• यह अध्ययि रोगी को कोई महत्वपूिष जोस्खम िहीूं िे िा है ।
गोपिीयिा: व्यस्िगि डे टा और मेतडकल ररकॉडष का उपयोग केवल अिुसूंिाि उद्दे श्य के तलए तकया
जाएगा और इसे गोपिीय रखा जाएगा। आईडी िूंबर के साि मरीजोूं की पहिाि की जाएगी।
स्वैस्च्छक भागीिारी: एक शोि अध्ययि में प्रवे श करिा स्वैस्च्छक है। यति रोगी एक शोि अध्ययि के
तलए स्वेच्छा से काम करिा है , िो उसे तकसी भी समय रोकिे का अतिकार है ।
तकसी भी प्रश्न के तलए:

सूंपकष करें :
डॉ. dIpk is<h
एिेस्थितसयोलॉजी और गहि िे खभाल तवभाग
गविष मेंट मे तडकल कॉले ज,
अमृ िसर -पूंजाब।
फोि िूं बर: +917903438297

25
 mrIj jwxkwrI SIt

isrlyK: “COMPARATIVE STUDY OF DEXMEDETOMIDINE, CLONIDINE AND

TRAMADOL FOR CONTROL OF POST OPERATIVE SHIVERING AFTER
SURGERY UNDER SPINAL ANAESTHESIA”.

pRm`uK jWckrqw: fw. dIpk isMG[

Ah`udw: post gRYjueyt ividAwrQI, ਅਨੈਸਥੀਸੀਓਲੋ ਜੀ ਅਤੇ ਇੰਟੈਸਸਵ ਕੇਅਰ ivBwg, srkwrI mYfIkl kwlj,
AMimRqsr[

ikrpw krky ies Pwrm nUM iDAwn nwl pVHo, jy qusI ies SIt ivclI BwSw jW koeI jwxkwrI nhIN
smJdy, qW ikrpw krky AiDAn krn vwly fwktr nwl ivcwr kro[

AiDAn dw “COMPARATIVE STUDY OF DEXMEDETOMIDINE,

audyS:
CLONIDINE AND TRAMADOL FOR CONTROL OF POST OPERATIVE
SHIVERING AFTER SURGERY UNDER SPINAL ANAESTHESIA”.

AiDAn bwry jwxkwrI: ieh nYiqkqw kmytI duAwrw mnjUr vrxnXog AiDAn hovygw[
AiDAn ivc mrIj dI BUimkw:
1. AiDAn dOrwn shI jwxkwrI Aqy sihXog pRdwn krnw[
2. ies AiDAn dy audyS leI hspqwl dy mYfIkl irkwrfW q`k phMuc dI AwigAw dyxw[
AiDAn ivc ih`sw lYx dy sMBwivq lwB kI hn?
 ies AiDAn dy nqIijAW dy ADwr qy pRwpq nqIijAW ivc fwktrW dy duAwrw ibmwrI dy
ielwj krn dy FMg nUM bdlx dI sMBwvnw hY ijs nwl mrIj dy Agly ishq pRbMD ivc lwB
ho skdw hY[
AiDAYn ivc ih`sw lYx kwrn sMBwvq joKm kI hn?
 ies AiDAn nwl mrIj nUM koeI mh`qvpUrn joKm nhI hY[
gupqqw:
in`jI fwty Aqy mYfIkl irkwrfW dI vrqoN Koz dy audySw leI kIqI jweygI Aqy aunW nUM gupq r`iKAw
jwvygw[mrIjw dI pCwx isrP AweI.fI nMbr nwl kIqI jweygI[
svY-ie`Ck
u BwgIdwrI: ies Koj AiDAn ivc dwKl hoxw svYie`Cuk hY[jy qusIN Koj AiDAn leI
svYieCuk nhI ho qW quhwnUM iksy vI smy rukx dw AiDkwr hY[

iksy vI pRSn leI sMprk:

fw. dIpk isMG

ਅਨੈਸਥੀਸੀਓਲੋ ਜੀ ਅਤੇ ਇੰਟੈਸਸਵ ਕੇਅਰ ivBwg
jUnIAr rYjIfYNt
srkwrI mYfIkl kwlj,
AMimRqsr, pMjwb[

mobwiel nM: +917903438297

26