Comparison of Intravenous Dexmedetomidine and Intravenous Fentanyl to Attenuate the Hemodynamic Stress Response to Tracheal Extubation: A Prospective Double Blinded Randomized Controlled Study

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COMPARISON OF INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY

DISSERTATION SUBMITTED TO THE TAMILNADU

DR.M.G.R. MEDICAL UNIVERSITY, CHENNAI

In partial fulfilment of the requirements for the degree of

M.D. BRANCH – X (ANAESTHESIOLOGY)

DEPARTMENT OF ANAESTHESIOLOGY TIRUNELVELI MEDICAL COLLEGE HOSPITAL

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CERTIFICATE BY THE GUIDE

This is to certify that the dissertation entitled “COMPARISON OF

INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS

FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS

RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY” submitted

by Dr.MANICKAVASAGAM.P, to the Tamilnadu Dr. M.G.R Medical

University, Chennai, in partial fulfillment of the requirement for the award of M.D. Degree Branch – X (ANAESTHESIOLOGY) is a bonafide research work carried out by him under my direct supervision & guidance.

Date:

Place: Tirunelveli Dr.T.MANOHARAN. M.D., DCH.,Senior Assistant Professor, Department of Anaesthesiology

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CERTIFICATE BY THE HEAD OF DEPARTMENT

This is to certify that the dissertation entitled “COMPARISON OF

INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS

FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS

RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY”is a

bonafide research work done by Dr.MANICKAVASAGAM.P, under the guidance and supervision of Dr.T.MANOHARAN. M.D., DCH., Senior Assistant Professor, Department of Anaesthesiology, Tirunelveli Medical College, Tirunelveli, in partial fulfilment of the requirements for the degree of M.D. in Anaesthesiology.

Dr R. Amutha Rani M.D.,

Professor and HOD of Anaesthesiology, Department of Anaesthesiology

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CERTIFICATE BY THE DEAN

I hereby certify that this dissertation entitled “COMPARISON OF

INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS

FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS

RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY” is a

record of work done byDr.MANICKAVASAGAM.P, under the guidance and supervision of Dr.T.MANOHARAN. M.D., DCH., Senior Assistant Professor, Department of Anaesthesiology, Tirunelveli Medical College, Tirunelveli, during his Postgraduate degree course period from 2016-2019. This work has not formed the basis for previous award of any degree.

Prof.Dr. S. M.Kannan,M.S., MCh.,(Uro)

Date :

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COPYRIGHT

DECLARATION BY THE CANDIDATE

I solemnly declare that the dissertation titled “COMPARISON OF

INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS

FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS

RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY” is a

bonafide and genuine research done by me under the guidance and supervision

of Dr.T.MANOHARAN. M.D., DCH., Senior Assistant Professor,

Department of Anaesthesiology, Tirunelveli Medical College, Tirunelveli.

The Tamil Nadu Dr.M.G.R. Medical University, Chennai shall have the

rights to preserve, use and disseminate this dissertation in print or electronic

format for academic/research purpose.

Place: Tirunelveli

Date: Dr.MANICKAVASAGAM.P.,M.B.B.S.,Postgraduate Student, M.D Anaesthesiology,

Department of Anaesthesiology, Tirunelveli Medical College,

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CERTIFICATE – II

This is to certify that this dissertation titled “COMPARISON OF

INTRAVENOUS DEXMEDETOMIDINE AND INTRAVENOUS

FENTANYL TO ATTENUATE THE HEMODYNAMIC STRESS

RESPONSE TO TRACHEAL EXTUBATION- A PROSPECTIVE

DOUBLE-BLINDED RANDOMIZED CONTROLLED STUDY” of the

candidate Dr.MANICKAVASAGAM.P with registration Number 201620303

for the award of M.D. Degree in the branch of ANAESTHESIOLOGY (X). I personally verified the urkund.com website for the purpose of plagiarism check. I found that the uploaded thesis file contains from introduction to conclusion page and result shows3 percentageof plagiarism in the dissertation.

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ACKNOWLEDGEMENT

I wish to express my heartfelt gratitude to our Dean

Prof.Dr. S. M.Kannan.M.S., MCh., Tirunelveli Medical College for allowing

me to do the study in this institution.

I would like to express my humble thanks to our professor & Head of the Department Prof . Dr R. Amutha Rani M.D., Department of Anaesthesiology, Tirunelveli Medical College, Tirunelveli, whose valuable guidance and constant help have gone a long way in the preparation of this dissertation.

I express my sincere thanks to my professors, Dr. R. Selvarajan. M.D

Dr.E.Ebenezer Joel Kumar.M.D,DNB., Dr.G.VijayAnand.M.D. for their

constant support, encouragement and suggestions which helped me greatly to expedite this dissertation .

I express my sincere thanks to my renowned teacher and my guide

Dr.T.Manoharan.M.D.,DCH., Senior Assistant Professor, Department of

Anaesthesiology, Tirunelveli Medical College, Tirunelveli, for his guidance, valuable suggestions and constant encouragement throughout the study.

I also offer my thanks to Prof.Dr.V.Pandy.M.S, and

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I express my thanks to all Assistant Professors, Staff members of the Department of Anaesthesiology and all my Postgraduates colleagues, C.R.R.I s and friends for their help during my study and preparation of this dissertation and also for their co-operation.

I wish to acknowledge my parents and family members for their everlasting blessings and encouragement.

I thank all my patients who participated in this study for their extreme patience and kind co-operation.

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ABBREVIATIONS

LIST OF ABBREVIATIONS USED

ABP Arterial blood pressure

ASA American society of Anaesthesiologists

BP Blood pressure

c-AMP Cyclic adenine monophosphate

CBF Cerebral blood flow

CNS Central Nervous System

CO2 Carbondioxide

DBP Diastolic blood pressure

DNS 5% dextrose in normal saline

ECG Electrocardiogram

EEG Electroencephalogram

GABA Gamma Amino Butryic Acid

HR Heart rate

(12)

ICU Intensive care unit

IM Intramuscular

LC Locus caeruleus

MAP Mean Arterial Pressure

MAC Minimum alveolar concentration

Nacl Sodium chloride

PaCO2 Partial pressure of arterial carbondioxide

PaO2 Partial pressure of arterial oxygen

PO2 Partial pressure of oxygen

PS Physical Status

SPO2 Saturation of partial pressure of oxygen

SBP Systolic blood pressure

SD Standard Deviation

TIVA Total intravenous anesthesia

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CONTENTS

S.NO TOPIC PAGE.NO

1. INTRODUCTION 1

2. REVIEW OF LITERATURE 3

3. AIM AND OBJECTIVES 7

4. ANATOMY OF AIRWAY REFLEXES 8

5. PHYSIOLOGY OF AIRWAY REFLEXES 15

6. PHARMACOLOGY OF DEXMEDETOMIDINE 15

7. PHARMACOLOGY OF FENTANYL 20

8. MATERIALS AND METHODS 25

9. OBSERVATION AND RESULTS 33

10. DISCUSSION 77

11. SUMMARY 84

12. CONCLUSION 87

ANNEXURE

 References

 Proforma

 Consent form

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S.No List of Tables Page No

1 MODIFIED ALDRETE SCORE 31

2. AGE DISTRIBUTION 34

3 GENDER DISTRIBUTION 35

4 SURGERY DURATION 36

5 ASA PHYSICAL STATUS 37

6 BODY MASS INDEX 38

7 HEART RATE 40

8 SYSTOLIC BLOOD PRESSURE 46

9 DIASTOLIC BLOOD PRESSURE 53

10 MEAN ARTERIAL PRESSURE 59

11 SPO2 65

12 EXTUBATION QUALITY SCORE 67

13 RAMSAY SEDATION SCORE 69

14 BRADYCARDIA 71

15 HYPOTENSION 73

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S.No List of Figures Page No

1. UPPER RESPIRATORY TRACT 8

2. NERVE SUPPLY OF LATERAL WALL OF NOSE 9

3 NERVE SUPPLY OF MEDIAL WALL OF NOSE 10

4 NERVE SUPPLY OF MOUTH AND PHARYNX 12

5 NERVE SUPPLY OF LARYNX 14

6 MOLECULAR STRUCTURE OF

DEXMEDETOMIDINE 15

7 DEXMEDETOMIDINE- ACTIONS IN BRAIN AND

BRAIN STEM 17

8 MOLECULAR STRUCTURE OF FENTANYL 20

9. AGE DISTRIBUTION 35

10 GENDER DISTRIBUTION 36

11 SURGERY DURATION 37

12 ASA PHYSICAL STATUS 38

13 BODY MASS INDEX 39

14 HEART RATE 45

15 SYSTOLIC BLOOD PRESSURE 52

16 DIASTOLIC BLOOD PRESSURE 58

17 MEAN ARTERIAL PRESSURE 64

18 SPO2 66

19 EXTUBATION QUALITY SCORE 68

20 RAMSAY SEDATION SCORE 70

21 BRADYCARDIA 72

22 HYPOTENSION 74

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INTRODUCTION

Endotracheal extubation is the translaryngeal removal of a tube from

trachea via nose or mouth. Complications that occur during and after

extubation are three times more common than that occurring during tracheal

intubation and induction of anaesthesia. Hypertension and tachycardia are

well documented events during extubation. Arrythmias, myocardial ischemia,

raised intracranial and intraocular pressures can occur1. There should be

absence of coughing, straining, laryngospasm, bronchospasm and breath

holding for smooth extubation2.

Drugs that have been recommended for the control of these

hemodynamic events including opioids, lignocaine, beta blockers, calcium

channel blockers and alpha 2 agonists3,4,5,6,7.

Dexmedetomidine is the highly selective alpha 2-receptor agonist

which has sympatholytic, anxiolytic, sedative and analgesic properties. It

reduces the cardiovascular responses in the perioperative period 7,8,9.

Fentanyl is an opioid that attenuates hemodynamic response to

extubation.It also decreases the airway reflexes to extubation and does not

(17)

It is found that an infusion of dexmedetomidine 1µg/kg is better than

fentanyl infusion of 1µg/kg before extubation to decrease the hemodynamic

surge during extubation. Dexmedetomidine 1µg/kg infusion has higher

sedation score compared to fentanyl 1µg/kg infusion10. Attenuation of stress

response to extubation by dexmedetomidine 0.5µg/kg infusion is as effective

as dexmedetomidine 1µg/kg infusion11.

Based on the previous studies it is found that 0.5µg/kg of

dexmedetomidine infusion attenuates the stress response to extubation as

effectively as 1µg/kg infusion of dexmedetomidine, hence in my study I have

compared 0.5µg/kg of dexmedetomidine infusion with 1 μg/kg of fentanyl

infusion to reduce the sedation score and adverse events associated with

(18)

REVIEW OF LITERATURE

Tanskanen et al12., conducted a double blind study in 54 patients who

underwent supratentorial brain surgery. They compared 2 different plasma

target concentration of dexmedetomidine given by continuous intravenous

infusion with the placebo. They concluded that trachea was extubated faster

without respiratory depression in the dexmedetomidine groups compared to

fentanyl group and dexmedetomidine increased perioperative hemodynamic

stability.

Turan G et al13., compared dexmedetomidine which was given at

0.5μg/kg intravenously for 1 minute before extubation with 20 ml of 0.9%

NaCl . They found that mean arterial pressure and heart rate are significantly

higher in the normal saline group. They concluded that dexmedetomidine

given at 0.5μg/kg intravenously for 60 seconds before extubation, made

extubation easier, stabilized hemodynamics, provided early recovery and

early neurological examination after intracranial surgeries.

Barka Bindu et al14., conducted a study in which 50 ASA grade I-II

patients , were randomized into dexmedetomidine and placebo groups. Group

A received 0.75μg/kg of dexmedetomidine in 100ml of normal saline while

(19)

Compared to placebo, dexmedetomidine group had better hemodynamic

stability and extubation quality.

Talke P et al15.,studied the effects of dexmedetomidine infusion in the

patients undergoing vascular surgeries. They concluded that attenuation of

rise in heart rate and plasma norepinephrine levels was better than placebo

during emergence from anesthesia. This attenuation is not observed in the

post operative period after emergence from anesthesia. They found that

dexmedetomidine did not affect the intraoperative anaesthetic or

postoperative analgesic requirements.

Arain et al16., conducted a study in which first group received

dexmedetomidine 1μg/kg for 10 minutes followed by 0.4 μg/kg/hr for 4 hours

30 minutes before completion of surgery. Second group received morphine

sulphate 0.08mg/kg 30 minutes before end of surgery. The reqirement of

morphine in the early postoperative period is reduced by 66% in the

dexmedetomidine group. There is also a significant decrease in the heart rate

in dexmedetomidine group compared to morphine group which is beneficial

in patients with coronary artery disease.

Aksu R et al17., compared intravenous dexmedetomidine 0.5 μg/kg with

intravenous fentanyl 1 μg/kg given before extubation in 40 patients who

(20)

hemodynamic response and airway reflexes to tracheal extubation better than

fentanyl. Moreover, dexmedetomidine does not prolong the recovery when

compared to fentanyl.

Liyakath et al10., compared dexmedetomidine (1 μg/kg) with fentanyl

(1μg/kg) with 150 patients divided into 3 groups of 50 each-normal saline,

dexmedetomidine and fentanyl groups in normotensives undergoing elective

surgeries. In this study Ramsay sedation score during initial 25 minutes

post-operatively among dexmedetomidine group found to be higher than other 2

groups which was statistically significant (p=0.003). Dexmedetomidine is

better than fentanyl in reducing stress response during emergence from

anaesthesia. Dexmedetomidine showed a better extubation quality score

compared to fentanyl or placebo.

Antony D et al11.,90 patients divided into 3 groups- group A received

intravenous dexmedetomidine 0.5µg/kg, group B received intravenous

dexmedetomidine 1µg/kg, group C received normal saline for a period of 10

minutes before the end of the surgery. They concluded that dexmedetomidine

infusion given at a dose of 0.5µg/kg before extubation reduces the stress

response to extubation similar to dexmedetomidine infusion of 1µg/kg.

Rani et al18., conducted a randomized, double blind controlled study

(21)

1µg/kg for a duration of 5 minutes at 15 minutes before the end of the

surgery. They found extubation quality to be better with the dexmedetomidine

group compared to fentanyl group.

Nishina K et al3., studied 60 patients undergoing elective gynecological

surgeries to compare the effects of 2 different doses of fentanyl 1µg/kg or 2

µg/kg on hemodynamic response during tracheal extubation. They found that

fentanyl 2µg/kg was better in attenuating the stress response to extubation

compared to fentanyl 1µg/kg without prolonging the recovery time.

Inomata S et al19., studied the effects of 2 different doses of fentanyl in

tracheal intubation and emergence with control in 150 patients anaesthetized

with sevoflurane. They found that fentanyl 2µg/kg bolus dose followed by

continuous infusion of 1µg/kg compared to fentanyl 1µg/kg bolus dose

followed by continuous infusion of 0.5µg/kg had better attenuation of

(22)

AIM OF THE STUDY

To compare the efficacy of intravenous dexmedetomidine with

intravenous fentanyl to decrease the stress response to tracheal extubation in

patients undergoing elective general surgeries.

Primary

objective-To compare 0.5 μg/kg of intravenous dexmedetomidine with 1 μg/kg

of intravenous fentanyl regarding variations in heart rate, systolic blood

pressure, diastolic blood pressure and mean arterial pressure,

extubation quality, breath holding, saturation.

Secondary

objective-To compare the adverse events (bradycardia,hypotension), sedation,

(23)

ANATOMY OF THEAIRWAY REFLEXES

Cricoid cartilage divides the airway into upper and lower respiratory tract.

FIG.NO.1 UPPER RESPIRATORY TRACT

The following consists the upper airway a. External nostrils

(24)

NASAL CAVITY:

Nasal septum seperates nasal cavity into two. Hard palate is parallel to the

floor of nasal cavity

The lateral wall has superior ,middle and inferior turbinates.The space below

these turbinates form the superior, ,middle and inferior meatuses respectively.

(25)

Lateral wall of nasal cavity is supplied by

1. Anterior ethmoidal nerves.

2. Posterior ethmoidal nerves.

3. Anterior - superior alveolar branch and

4. Infra orbital branch of maxillary nerve.

Medial wall of nasal cavity is supplied by

1. Anterior ethmoidal nerve

2. Anterior superior alveolar nerve

3. Medial posterior superior nasal nerve and

4. Nasopalatine nerve20,21.

(26)

ORAL CAVITY:

The oral cavity has the following

1) Hard palate

2) Soft palate

3) Upper and lower dentition

4) Tongue

5) Floor of the mouth

6) The major salivary glands.

The oral cavity is supplied by

a. Trigeminal nerve,

b. Facial nerve,

c. Glossopharyngeal nerve and

(27)
(28)

PHARYNX:

 Pharynx consists of nasopharynx, oropharynx, laryngopharynx.

 Nasopharynx extends from skull base to soft palate.

 Oropharynx extends from soft palate to body of hyoid bone.

 Laryngopharynx extends from body of hyoid bone to lower border of

cricoid cartilage.

Nerve supply of pharynx:

The pharyngeal walls, upper part of epiglottis and the base of the

tongue are supplied by the glossopharyngeal nerve.

The supraglottic parts and the lower part of epiglottis are supplied by

(29)

LARYNX:

In adults, larynx extends from C3 vertebra to C6 vertebra.

FIG.NO.5. NERVE SUPPLY OF LARYNX

The mucous membrane of larynx is supplied by internal laryngeal

branch of superior laryngeal nerve above the vocal cords. Recurrent laryngeal

nerve is sensory to mucous membrane below the vocal cords.

Cricothyroid is supplied by external laryngeal branch of superior laryngeal

(30)

PHYSIOLOGY OF AIRWAY REFLEXES

Afferent fibres from the larynx reach the medulla via nucleus tractus

solitarius through the glossopharyngeal and vagus nerves.

During tracheal extubation, there is reflex activation of vasomotor

center in the medulla which increases sympathetic discharge to heart, blood

vessels and adrenal medulla. Adrenal medulla secretes catecholamines. The

final effect is tachycardia, hypertension, increased intraocular and intracranial

pressures22.

DEXMEDETOMIDINE

Dexmedetomidine is an α2 agonist. It belongs to imidazole subclass of

α2 agonists. It is more selective for α2 agonist (α2:α1=1620:1) than clonidine

(α2:α1=220:1). α2 receptors are pre-synaptic receptors.

(31)

Pontine nucleus locus coeruleus is the predominant site of action of

dexmedetomidine. α2 receptors are more concentrated in this nucleus. This

nucleus is responsible for most of the action of sympathetic system like

vigilance, memory, analgesia and arousal.

They inhibit the release of norepinephrine to the ventrolateral preoptic

nucleus, GABA and galanin release to tuber mammillary nucleus is increased,

producing a decrease in the histamine release in the cortical and sub-cortical

(32)

FIG.NO.7. DEXMEDETOMIDINE- ACTIONS IN BRAIN AND BRAIN

(33)

α2 receptors exhibit their action by inhibiting adenyl cyclase, calcium

and potassium ion channels.

Patients while sedated by dexmedetomidine have a calm sleep but is

easily arousable. They do not have depressive action on ventilation unlike

benzodiazepines.

Dexmedetomidine have an elimination t1/2 of 2 to 3 hours. They are

highly protein bound(>90%). They have high first pass metabolism in the

liver. The methyl and glucuronide conjugates are excreted in the kidneys.

They have weak inhibitory action on the cytochrome P450 enzymes.

Dexmedetomidine have an ability to increase the MAC values of

inhalational anaesthetic. Its main side effect is circulatory and hemodynamic

(i.e. hypotension and bradycardia) due to sympatholytic and vagommimetic

action23.

Dexmedetomidine in high doses can be used in total intravenous

anaesthesia.

It is used with lignocaine for IV regional anaesthesia.

It can be used intrathecally. Intrathecal dexmedetomidine 3 μg is as

(34)

intrathecal fentanyl 25 μg are comparable when used with bupivacaine. They

produce more sensory and motor block.

It can be used epidurally with local anaesthetics. It increases density of

motor blockade, duration of sensory and motor block. It decreases the need

for post-operative analgesia24.

It can be used intramuscularly or intravenously as a premedication to

general anaesthesia. It can be used intraoperatively to produce sedation, to

decrease cardiovascular stress response by decreasing concentration of

norepinephrine.

It can be used intravascularly as infusion preoperatively to attenuate

cardiovascular stress response to laryngoscopy and intubation. It be used

intravascularly as infusion 10 to 15 minutes before extubation to decrease the

cardiovascular stress response to extubation.

It can be used post-operatively as a sedative and analgesic in

intravascular form.

The luteal phase of menstrual cycle have a decrease in oxidative

metabolism of anaesthetic drugs. There is sedative effect of progesterone and

its metabolites through acton on the GABA receptor complex. So,there will

(35)

FENTANYL

Structure

 Fentanyl is a phenylpiperidine-derivative

 Structurally related to meperidine(pethidine)

FIG.NO.8. MOLECULAR STRUCTURE OF FENTANYL

History

 synthetic

(36)

 First synthesized in 1960 by Janssen Pharmaceutica during an assay of

meperidine derivatives

 Released as the citrate salt under the trade name Sublimaze.

Comparison with morphine with single dose of fentanyl-iv route

 Greater lipid solubility facilitates passage through blood-brain barrier

 Greater potency -as analgesic, fentanyl is 75 to 125 times more

potent than morphine.

More rapid onset

Plasma concentrations of fentanyl correlate well with CSF

concentrations.

 Rapid redistribution to inactive tissue sites such as fat and skeletal

muscles with associated decrease in plasma concentration

 Shorter duration of action

Pharmacokinetics

 Distinct delay between the peak plasma fentanyl concentration and the

(37)

Effect-site equilibration time between blood and the brain is 6.4

minutes.

Clinical uses:

 Fentanyl is used in a wide range of doses from 0.5 to 150μg/kg.

 1 to 2µg/kg intravenous route to provide analgesia.

 2 to 20µg/kg intravenous route may be administered as an adjuvant to

inhaled anaesthetics in an attempt to blunt circulatory responses to

Direct laryngoscopy for intubation of the trachea.

Sudden changes in the level of surgical stimulation.

 Administration of fentanyl 1.5 or 3µg/kg IV 5 minutes before induction

of anaesthesia decreases the subsequent doses of isoflurane or

desflurane with 60% nitrous oxide needed to block the sympathetic

nervous system response to surgical stimulation.

 Fentanyl can be used intrathecally, transdermally,transmucously also.

Side effects:

(38)

Ion trapping- sequestration of fentanyl in acidic gastric fluid

which could then be absorbed from the more alkaline small

intestine back into circulation.

Washout of opioids from the lungs- as ventilation to perfusion

relationships are reestablished in the postoperative period.

Cardiovascular effects:

 Bradycardia is more prominent with fentanyl and may lead to

occasional decrease in blood pressure and cardiac output.

 Fentanyl even in large doses (50μg/kg) IV does not evoke histamine

release.

 Carotid sinus baroreceptor reflex control of heart rate is markedly

depressed by fentanyl, when administered to neonates.

 As cardiac output is rate dependent in neonates, changes in systemic

blood pressure during fentanyl anesthesia have to be carefully

considered.

CNS effects:

 Seizure-like activity have been described after rapid IV administration

(39)

 Opioids might produce a form of myoclonus secondary to depression of

inhibitory neurons that would produce a clinical picture of seizure

activity in the absence of EEG changes.

 Administration of fentanyl to head injury patients has been associated

with a modest increases (6 to 9 mmHg) in ICP despite maintenance of

an unchanged PaCo2.

 Increase in ICP may be due to autoregulatory decreases in cerebral

vascular resistance due to decreases in systemic blood pressure

resulting in vasodilation, increases blood volume, and increased ICP.

 Fentanyl attenuate skeletal muscle movement at doses that have little

effect on the EEG. Thus movement in response to surgical skin incision

may not be the most appropriate measure for assessing consciousness.

Drug interactions:

 The opioid-benzodiazepine combination produce marked synergism

with respect to hypnosis and depression of ventilation.

 Analgesic concentrations of fentanyl potentiate the effects of

(40)

MATERIALS AND METHODOLOGY

Source of the study:

Patients posted for elective general surgeries under general anaesthesia

at Tirunelveli Medical College Hospital.

Study design:

A prospective, double-blinded, randomized controlled study.

Duration of study:

8 months- January 2018 to August 2018.

Sample size:

Calculated using the following formula based on the earlier study by

Liyakath et al comparing effects of dexmedetomidine (1 μg/kg) with fentanyl

(41)

Considering 10% compensation for “drop out” or “loss of follow up” sample

size is taken as 60 for each groups.

Allocation of groups:

Using sealed enveloped technique patients were categorised into 3 different

groups.

• Group N: (n=60) Received 100 ml of normal saline.

• Group F: (n=60) Received fentanyl (1μg/kg) in 100 ml of normal

saline.

• Group D: (n=60) Received dexmedetomidine (0.5μg/kg) in 100 ml of

(42)

Inclusion criteria

1. ASA (American Society of Anaesthesiologist) grade I and II of either

sex,

2. Age 18 to 65 years

3. Scheduled under general anaesthesia for elective general surgeries

4. Duration of surgery- 60 to 180 minutes.

Exclusion criteria

Patients who are or with

1. Allergic to dexmedetomidine or fentanyl

2. Cardiovascular disorder

3. Respiratory disorder,

4. Diabetes,

5. Hypertension,

6. Obesity(BMI= or >30 kg/m2)

7. Difficult airway (Modified Mallampatti Grade III and IV)

8. Medications that affect heart rate or blood pressure,

9. Pregnant,

10.History of sleep apneoa,

11.Hepatic impairment,

(43)

METHODOLOGY:

After getting institutional ethical committee approval, pre-anaesthetic

assessment was made. Informed written consent was got from all the patients.

Age, gender, body mass index were recorded.

All the patients were kept nil oral 8 hours before surgery.

Patients were given Inj. Glycopyrrolate 10μg/kg iv, Inj. Midazolam 40μg/kg

iv, Inj. Ondansetron 100μg/kg iv, Inj. Ranitidine 1mg/kg iv as premedication.

Three lead electrocardiogram, non invasive blood pressure, pulse oximeter

and capnograph were attached for monitoring.

100% oxygen for 3 minutes was given as pre-oxygenation.

Induction of the patient is done with Inj. Fentanyl 2μg/kg iv, Inj. Thiopentone

sodium 5 mg/kg iv, Inj. Atracurium 0.5 mg/kg iv and intubation was done

with a suitable endotracheal tube.

Oxygen and nitrous oxide were used in the ratio of 40:60 for the maintenance

of anaesthesia along with isoflurane 0.8 to 1.5%. Inj. Atracurium 0.125mg/kg

iv was repeated at intervals with capnograph monitoring for the maintenance

(44)

Volume replacement and maintenance was done with ringer lactate and DNS.

Isoflurane was cut off 10 minutes before anticipated extubation time in all the

3 groups.

Test drugs were prepared by the persons not involved in the study and

were handed over to the anaesthetists ,who were unaware of the drugs. Group

N patients received 100 ml of normal saline over a period of 10 minutes

before the anticipated extubation time. Group F patients received fentanyl

1μg/kg in 100 ml of normal saline over a period of 10 minutes before the

anticipated extubation time. Group D received dexmedetomidine 0.5μg/kg in

100 ml of normal saline over a period of 10 minutes before the anticipated

extubation time.

Patients were reversed with Inj. Neostigmine 50 μg/kg iv and

Inj.Glycopyrrolate 10μg/kg iv after adequate spontaneous breathing efforts.

Baseline hemodynamic parameters like heart rate and systolic, diastolic and

mean arterial blood pressures were recorded. Baseline saturation is also

recorded.

All the above parameters were recorded after induction and intubation,

10 minutes before extubation, 5 minutes before extubation, during extubation

(45)

EXTUBATION QUALITY SCORE

Extubation response is calculated on a 5 point depending on patient’s

response13.

1) Patient is having no cough.

2) Endotracheal extubation is smooth and the patient is havingcough

-one or two times (minimal)

3) Patient is having cough - three or four times(moderate)

4) Patient is having cough - five to ten times(severe)

5) Patient is having cough - more than ten times or laryngospasm or

breath holding. Extubation is poor and the patient is restless.

RAMSAY SEDATION SCORE

Postoperative sedation was assessed on a 6 point scale(Ramsay scale) 26

1. Anxious or agitated and restless or both

2. Cooperative, oriented and tranquilized.

3. Drowsy but responds to commands.

4. Asleep, brisk response to light glabellar tap or loud auditory stimulus.

5. Asleep, sluggish response to light glabellar tap or loud auditory

stimulus.

(46)

MODIFIED ALDRETE SCORE

TABLE NO.1. MODIFIED ALDRETE SCORE

Aldrete scoring was also recorded at 25minutes following extubation before

sending the patients from the recovery room to the wards27,.

Hypotension was defined as a decrease of MAP ≥ 20% from base line. Any

hypotension was corrected with IV fluids. Inj. Ephedrine 100μg/kg was kept

(47)

Bradycardia was defined as heart rate less than 60 beats per minute. Any

bradycardia withHR <45 was planned to treat with inj. atropine 10 µg/kg.

Breath holding is defined as not breathing for ≥20 seconds, and desaturation

resulting in a decrease in SpO 2 >5% from baseline.

Statistical analysis are made with IBM SPSS 16.0 software and P value

(48)

RESULTS

One way ANOVA test is used for Continuous variables like

1. Age

2. Surgery duration

3. Body Mass Index

4. Heart rate

5. Systolic Blood Pressure

6. Diastolic Blood Pressure

7. Mean Arterial Pressure.

Pearson’s Chi-squared test is used for Categorical variables like

1. ASA Physical Status

2. Gender

3. Extubation Quality Score

4. Ramsay Sedation Score

5. Bradycardia

6. Hypotension

(49)

DEMOGRAPHIC PROFILE:

TABLE NO.2.DEMOGRAPHIC PROFILE: AGE DISTRIBUTION

Groups N Mean Std.Deviation P value

Age

Normal Saline 60 37.97 10.31

0.586

Fentanyl 60 39.52 11.13

Dexmedetomidine 60 39.92 11.22

Total 180 39.13 10.86

Table shows mean age in normal saline group is 37.97±10.31. Mean

age in Fentanyl group is 39.52±11.13. Mean age in Dexmedetomidine group

(50)

FIGURE NO.9. AGE DISTRIBUTION

DEMOGRAPHIC DETAILS OF THE STUDY

TABLE NO.3. DEMOGRAPHIC DETAILS OF THE STUDY-GENDER DISTRIBUTION

Normal saline group has 56.7% females and 43.3% males. Fentanyl group has

65% females and 35% males. Dexmedetomidine group has 46.7% females

and 53.3% males. The P value is found to be>0.05 and hence it is statistically

insignificant.

37.97

39.52

39.92

36.50 37.00 37.50 38.00 38.50 39.00 39.50 40.00 40.50

Normal Saline Fentanyl Dexmedetomidine

Ag

e

in

Y

ear

s

Groups

Age Distribution

Gender

P value Female Male

group Normal Saline 34 26

0.190

Fentanyl 39 21

Dexmedetomidine 28 32

(51)

FIGURE NO.10. GENDER DISTRIBUTION

SURGERY DURATION

TABLE NO.4.SURGERY DURATION

The duration of surgery in the Normal saline group is 100.23±32.08 minutes.

The duration in the Fentanyl group is 104.31±31.82 minutes. The duration in

the Dexmedetomidine group is 94.67±33.73 minutes. The P value is found to

be>0.05 and hence it is statistically insignificant.

34 39 28 26 21 32 0 5 10 15 20 25 30 35 40 45

Normal Saline Fentanyl Dexmedetomidine

N O . o f p er so ns Groups

GENDER DISTRIBUTION

Female Male Surgery duration

(in minutes) N Mean

Std.

Deviation P value

Normal Saline 60 100.23 32.08 0.271

Fentanyl 60 104.31 31.82

Dexmedetomidine 60 94.67 33.73

(52)

FIGURE NO.11. SURGERY DURATION

ASA PHYSICAL STATUS

TABLE NO.5. ASA PHYSICAL STATUS

Group ASA PS P value

I II

Normal Saline 31 29

0.766

Fentanyl 29 31

Dexmedetomidine 27 33

Total 87 93

In the Normal saline group 51.7% were in the ASA PS I and 48.3% were in

the ASA PS II. In the Fentanyl group 48.3% were in the ASA PS I and 51.7%

were in the ASA PS II. In the Dexmedetomidine group 45% were in the ASA

PS I and 55% were in the ASA PS II. The P value is found to be>0.05 and

hence it is statistically insignificant.

100.23 104.31 94.67 88.00 90.00 92.00 94.00 96.00 98.00 100.00 102.00 104.00 106.00

Normal Saline Fentanyl Dexmedetomidine

(53)

FIGURE NO.12. ASA PHYSICAL STATUS

BODY MASS INDEX

TABLE NO.6. BODY MASS INDEX

BMI(kg/m2) N Mean Std.

Deviation P value

Normal Saline

60 22.84 2.22

0.997

Fentanyl 60 22.87 2.22

Dexmedetomidine

60 22.85 2.28

Total 180 22.85 2.23

31

29

27

29 31

33

0 5 10 15 20 25 30 35

Normal Saline Fentanyl Dexmedetomidine

N

o.

o

f P

er

so

ns

GROUP

ASA PHYSICAL STATUS

(54)

The Body mass index in the Normal saline group is found to be 22.84±2.22.

The Body mass index in the Fentanyl group is found to be 22.87±2.22. The

Body mass index in the Dexmedetomidine group is found to be 22.85±2.28.

The P value is found to be>0.05 and hence it is statistically insignificant.

FIGURE NO.13.BODY MASS INDEX

22.84

22.87

22.85

22.80 22.81 22.82 22.83 22.84 22.85 22.86 22.87 22.88 22.89 22.90

Normal Saline Fentanyl Dexmedetomidine

BM

I (

in

k

g/

m

2)

Group

(55)

HEART RATE

TABLE NO.7.HEART RATE

Normal

Saline Fentanyl Dexmedetomidine Pval

ue Heart rate N or m al Sa line Std. D ev ia tio n Fe nta ny l Std. D ev ia tio n D ex m ede to m id ine Std. D ev ia tio n

base_hr 76.12 5.52 76.13 4.59 77.72 5.07 .143

indu_hr 99.28 7.26 101.37 7.45 101.40 7.86 .214

bef_ex_10 78.75 6.56 78.77 6.00 77.93 6.66 .719

bef_ex_5 75.00 6.55 71.44 5.71 70.58 8.75 .089

during_ex 100.60 7.15 93.32 6.78 84.45 10.99 .000

aft_2 96.10 7.56 89.90 8.34 80.42 9.18 .000

aft_4 91.60 7.27 86.65 8.20 75.83 9.44 .000

aft_6 88.05 7.33 83.88 7.67 74.08 8.72 .000

aft_8 84.62 6.24 81.28 7.88 72.78 8.39 .000

aft_10 81.81 6.36 79.90 8.65 71.93 7.07 .000

aft_25 82.13 5.66 80.10 8.00 73.17 6.94 .000

aft_40 80.50 5.59 77.97 7.07 72.13 6.49 .032

aft_55 78.48 5.50 76.78 6.59 71.97 6.85 .025

aft_70 76.80 5.02 75.70 5.92 71.87 5.98 .000

aft_85 76.33 5.86 75.30 5.77 72.53 5.97 .002

aft_100 75.53 5.74 75.23 5.87 72.40 5.87 .006

aft_115 74.97 5.86 74.60 7.01 72.52 5.71 .069

(56)

The mean heart rate at baseline, during induction and intubation, before

extubation, during extubation and after extubation was calculated in the

normalsaline, fentanyl, dexmedetomidine groups.

The mean heart rate at baseline, after induction and intubation, 10

minutes before extubation, 5 minutes before extubation in the normal saline

group were 76.12±5.52, 99.28±7.26, 78.75±6.56, 75.00±6.55.

The mean heart rate at baseline, after induction and intubation, 10

minutes before extubation, 5 minutes before extubation in the fentanyl group

were 76.13±4.59, 101.37 ±7.45, 78.77±6.00, 71.44±5.7.

The mean heart rate at baseline, after induction and intubation, 10

minutes before extubation, 5 minutes before extubation in the

dexmedetomidine group were 77.72±5.07, 101.40±7.86, 77.93±6.66,

70.58±8.75.

Statistical analysis showed a P value of heart rate at baseline, after

induction and intubation, 10 minutes before extubation, 5 minutes before

extubation were 0.143, 0.214, 0.719, 0.089 which were statistically

(57)

The mean heart rate during extubation in the normal saline group was

100.60±7.15, in the Fentanyl group was 93.32±6.78, in the dexmedetomidine

group was 84.45±10.99.

Statistical analysis showed a P value of heart rate during extubation

was <0.05 and hence statistically significant.

The mean heart rate of the normal saline group after extubation at

2,4,6,8,10,25,40,55,70,85,100 minutes are 96.10± 7.56, 91.60± 7.27,

88.05±7.33, 84.62± 6.24, 81.81± 6.36, 82.13±5.66, 78.48± 5.59, 80.50± 5.50,

76.80± 5.02, 76.33± 5.86, 75.53± 5.74.

The mean heart rate of the fentanyl group after extubation at

2,4,6,8,10,25,40,55,70,85,100 minutes are 89.90± 8.34, 86.65± 8.20, 83.88±

7.67, 81.28±7.88,79.90± 8.65, 80.10± 8.00, 77.97± 7.07, 76.78± 6.59, 75.70±

5.92, 75.30± 5.77, 75.23± 5.87.

The mean heart rate of the dexmedetomidine group after extubation at

2,4,6,8,10,25,40,55,70,85,100 minutes are 80.42± 9.18, 75.83± 9.44, 74.08±

8.72, 72.78± 8.39, 71.93± 7.07, 73.17± 6.94, 72.13± 6.49, 71.97± 6.85,

71.87± 5.98, 72.53± 5.97, 72.40± 5.87.

(58)

0.000, 0.032, 0.025, 0.000, 0.002,0.006. These P values are statistically

significant.

The mean heart rate of the normal saline group after extubation at 115,

130 minutes were 74.97± 5.86,74.62± 5.09. The mean heart rate of the

fentanyl group after extubation at 115, 130 minutes were 74.60± 7.01, 74.47±

5.63. The mean heart rate of the dexmedetomidine group after extubation at

115, 130 minutes were 72.52± 5.71, 73.03± 5.52.

Statistical analysis reveals a P value of heart rate after extubation at

115, 130 minutes were 0.069,0.213. These P values are statistically

insignificant.

The mean difference of heart rate betweendexmedetomidine and

fentanylgroups at baseline, after induction and intubation, 10 minutes before

extubation, 5 minutes before extubation are1.58, 0.03, -0.83, -0.86.

Statistical analysis reveals a P value for the mean difference of heart

rate between dexmedetomidine and fentanyl groups at baseline, after

induction and intubation, 10 minutes before extubation, 5 minutes before

extubation are 0.268, 1.0, 1.0, 0.452 respectively and hence statistically

(59)

The mean difference of heart rate between dexmedetomidine and

fentanyl groups during extubation was -8.87. P value was found to be 0.00

and hence statistically significant.

The mean difference of heart rate between dexmedetomidine and

fentanyl groups after extubation at 2, 4, 6, 8,10,25, 40, 55, 70, 85, 100

minutes are 9.48, 10.82, 9.80, 8.5, 7.97, 6.93, 5.83, 4.82, 3.83, 2.77,

-2.83 respectively.

Statistical analysis reveals a P value for the mean difference of heart

rate between dexmedetomidine and fentanyl groups after extubation at 2, 4, 6,

8,10,25, 40, 55, 70, 85, 100 minutes as 0, 0, 0, 0, 0, 0, 0, 0, 0.001, 0.032,

0.025 respectively and hence statistically significant.

The mean difference of heart rate between dexmedetomidine and

fentanyl groups after extubation at 115, 130 minutes are -2.08, -1.43

respectively and P value for the mean difference of heart rate between

dexmedetomidine and fentanyl groups after extubation at 115, 130 minutes

(60)

FIGURE NO.14 HEART RATE

0.00 20.00 40.00 60.00 80.00 100.00 120.00

HE

AR

T

RA

TE

/M

IN

TIME

HEART RATE

(61)

SYSTOLIC BLOOD PRESSURE

TABLE.NO.8.SYSTOLIC BLOOD PRESSURE

Descriptive Statisticsa

Normal

Saline Fentanyl Dexmedetomidine

P value Nor m al S al in e St d. De vi at ion Fe nt an yl St d. De vi at ion De xm ed et om id in e St d. De vi at ion

b_sys 126.07 8.44 127.63 8.21 127.75 9.34 0.496 ind_sys 149.18 14.41 150.20 10.00 151.77 8.89 0.456 bef_10_sys 130.27 7.06 129.10 9.00 130.12 6.46 0.658 bef_5_sys 127.97 7.41 125.98 6.69 125.25 7.24 0.099 extu_sys 153.07 8.64 136.49 5.70 135.40 8.35 0 aft_sys_2 145.55 8.40 131.27 7.21 129.98 5.78 0 sys4 140.45 6.19 128.34 6.58 126.82 5.93 0 sys6 135.70 5.79 126.34 4.92 124.32 6.95 0 sys8 132.15 5.55 125.13 4.81 122.90 6.22 0 sys10 129.90 4.62 126.08 5.00 121.82 6.03 0 sys25 129.47 4.32 125.90 5.08 123.47 6.32 0 sys40 127.53 4.39 124.57 5.12 122.63 5.65 0 sys55 126.27 4.11 124.32 5.30 122.27 6.20 0 sys70 125.40 4.63 124.40 5.99 122.80 5.57 0.032 sys85 124.30 4.71 124.00 5.41 122.27 5.43 0.072 sys100 124.17 5.44 123.50 5.64 121.83 4.93 0.051 sys115 123.63 5.52 122.77 5.25 121.43 4.62 0.064 sys130 122.82 4.89 122.50 5.10 121.17 4.57 0.145

The mean systolic blood pressure at baseline, during induction and intubation,

before extubation, during extubation and after extubation was calculated in

(62)

The mean systolic blood pressure at baseline, after induction and intubation,

10 minutes before extubation, 5 minutes before extubation in the normal

saline group were 126.07± 8.44, 149.18± 14.41, 130.27± 7.06, 127.97± 7.41.

The mean at systolic blood pressureat baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation in the

Fentanyl group were 127.63± 8.21,150.20± 10.00, 129.10± 9.00, 125.98±

6.69 .

The mean at systolic blood pressure at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation in the

dexmedetomidine group were 127.75± 9.34, 151.77± 8.89, 130.12±

6.46,125.25± 7.24.

Statistical analysis showed a P value of systolic blood pressure at

baseline, after induction and intubation, 10 minutes before extubation, 5

minutes before extubation were 0.496,0.456, 0.658, 0.099 which were

statistically insignificant.

The mean systolic blood pressure during extubation in the normal

saline group was 153.07± 8.64, in the Fentanyl group was 136.49± 5.70, in

(63)

Statistical analysis showed a P value of systolic blood pressureduring

extubation was 0.000 and hence statistically significant.

The mean systolic blood pressureof the normal saline group after

extubation at 2,4,6,8,10,25,40,55,70 minutes are 145.55±8.40, 140.45± 6.19,

135.70± 5.79, 132.15 ±5.55, 129.90±4.62, 129.47±4.32, 127.53±4.39, 126.27

±4.11, 125.40±4.63.

The mean systolic blood pressureof the fentanyl group after extubation

at 2,4,6,8,10,25,40,55,70minutes are 131.27±7.21, 128.34±6.58, 126.34±4.92,

125.13±4.81, 126.08±5.00, 125.90±5.08, 124.57±5.12, 124.32±5.30, 124.40±

5.99.

The mean systolic blood pressure of the dexmedetomidine group after

extubation at 2,4,6,8,10,25,40,55,70minutes are 129.98±5.78, 126.82±5.93,

124.32±6.95, 122.90±6.22, 121.82± 6.03, 123.47±6.32 ,122.63±5.65, 122.27±

6.20,122.80± 5.57.

Statistical analysis reveals a P value of systolic blood pressureafter

extubation at 2,4, 6,8, 10, 25, 40, 55, 70 minutes as 0.000, 0.000, 0.000,

0.000, 0.000, 0.000, 0.032, 0.025, 0.032. These P values are statistically

(64)

The mean systolic blood pressureof the normal saline group after

extubation at 85,100,115, 130 minutes were 124.30±4.71, 124.17±5.44,

123.63±5.52,122.82± 4.89. The mean systolic blood pressureof the fentanyl

group after extubation at 85,100,115, 130 minutes were124.00 ±5.41,

123.50±5.64, 122.77±5.25,122.50 ±5.10. The mean systolic blood pressureof

the dexmedetomidine group after extubation at 85,100,115, 130 minutes were

122.27 ±5.43, 121.83±4.93, 121.43±4.62, 121.17±4.57.

Statistical analysis reveals a P value of systolic blood pressureafter

extubation at 85,100,115, 130 minutes were 0.072, 0.051, 0.064, 0.145

respectively. These P values are statistically insignificant.

The mean difference of systolic blood pressure between

dexmedetomidine and fentanyl groups at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation are

0.12,1.57,1.02, -0.73.

Statistical analysis reveals a P value for the mean difference of systolic

blood pressure between dexmedetomidine and fentanyl groups at baseline,

after induction and intubation, 10 minutes before extubation, 5 minutes before

(65)

The mean difference of systolic blood pressure between

dexmedetomidine and fentanyl groups during extubation was -1.09. P value

was found to be 0.872 and hence statistically insignificant.

The mean difference of systolic blood pressure between

dexmedetomidine and fentanyl groups after extubation at 2, 4, 6, 8 minutes

are -1.29,-1.52,-2.02,-2.23 respectively.

Statistical analysis reveals a P value for the mean difference of systolic

blood pressure between dexmedetomidine and fentanyl groups after

extubation at 2, 4, 6, 8minutes as 0.540,0.406,0.114,0.068 respectively and

hence statistically insignificant.

The mean difference of systolic blood pressure between

dexmedetomidine and fentanyl groups after extubation at 10,25 minutes are

-4.27,-2.43 respectively and P value for the mean difference of systolic blood

pressure between dexmedetomidine and fentanyl groups after extubation at

10,25 minutes are 0.000, 0.039 respectively , hence statistically significant.

The mean difference of systolic blood pressure between

dexmedetomidine and fentanyl groups after extubation at 40, 55, 70, 85,

(66)

between dexmedetomidine and fentanyl groups after extubation at 40, 55, 70,

85, 100,115, 130 minutes are 0.116,0.104,0.325,0.208,0.268,0.472,0.404

(67)

FIGURE NO.15.SYSTOLIC BLOOD PRESSURE

0.00 20.00 40.00 60.00 80.00 100.00 120.00 140.00 160.00 180.00

Sy

st

ol

ic

B

P

in

m

m

Hg

Time

SYSTOLIC BLOOD PRESSURE

(68)

DIASTOLIC BLOOD PRESSURE

TABLE.NO.9 DIASTOLIC BLOOD PRESSURE

Descriptive

Statisticsa

Normal

Saline Fentanyl Dexmedetomidine valueP

N or m al S aline Std. D evi ation Fe ntanyl Std. D evi ation D exm ede to m idine Std. D evi ation

b_dia 75.37 5.00 74.17 5.28 74.87 6.37 0.498

ind_dia 96.10 12.27 96.22 8.04 96.97 7.55 0.864

bef_10_dia 78.35 4.80 77.40 6.31 76.83 5.04 0.304

bef_5_dia 74.52 5.80 74.73 6.53 73.45 7.06 0.035

extu_dia 98.72 7.63 82.56 5.82 81.25 6.66 0

aft_dia_2 91.85 6.82 79.16 5.92 77.70 4.49 0

dia4 88.15 5.75 77.08 5.46 75.50 4.61 0

dia6 84.43 5.55 74.92 5.35 73.23 5.18 0

dia8 81.60 5.27 73.80 4.75 71.95 5.20 0

dia10 79.58 5.09 77.87 5.02 71.65 5.10 0

dia25 79.07 4.86 77.77 4.57 72.37 4.95 0

dia40 77.30 4.76 76.77 4.39 71.80 4.89 0

dia55 76.43 4.69 75.72 4.99 71.20 4.56 0

dia70 75.23 4.50 74.93 4.79 71.73 4.89 0

dia85 74.97 4.68 74.87 4.47 71.53 4.28 0

dia100 74.43 4.53 74.20 4.18 71.40 4.17 0

dia115 73.27 4.83 74.03 3.69 71.33 3.84 0.002

dia130 73.08 4.71 73.23 3.57 71.30 4.21 0.021

The mean diastolic blood pressure at baseline, during induction and

intubation, before extubation, during extubation and after extubation was

(69)

The mean diastolic blood pressure at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation in the

normal saline group were 75.37±5.00, 96.10±12.27, 78.35±4.80, 74.52 ±5.80.

The mean diastolic blood pressure at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation in the

fentanyl group were 74.17±5.28, 96.22±8.04,77.40 ±6.31, 74.73±6.53.

The mean diastolic blood pressure at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation in the

dexmedetomidine group were 74.87±6.37, 96.97 ±7.55, 76.83±5.04,

73.45±7.06.

Statistical analysis showed a P value of diastolicblood pressure at

baseline, after induction and intubation, 10 minutes before extubation, 5

minutes before extubation were 0.498, 0.864, 0.304,0.035 hence the mean

diastolic blood pressure at baseline, after induction and intubation, 10 minutes

before extubation between the groups were statistically insignificant and the

mean diastolic blood pressure 5 minutes before extubation between groups

(70)

The mean diastolic blood pressure during extubation in the normal

saline group was 98.72 ±7.63, in the Fentanyl group was 82.56±5.82, in the

dexmedetomidine group was 81.25±6.66.

Statistical analysis showed a P value of diastolic blood pressureduring

extubation was 0.000 and hence statistically significant.

The mean diastolic blood pressureof the normal saline group after

extubation at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are 91.85±6.82,

88.15±5.75,84.43 ±5.55,81.60 ±5.27,79.58 ±5.09,79.07 ±4.86,77.30

±4.76,76.43±4.69,75.23±4.50,74.97±4.68,74.43±4.53,73.27±4.83,73.08±4.7.

The mean diastolic blood pressureof the fentanyl group after extubation

at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are 79.16 ±5.92,

77.08±5.46,74.92±5.35,73.80±4.75,77.87±5.02,77.77±4.57,76.77±4.39,75.72

±4.99,74.93±4.79,74.87±4.47,74.20±4.18,74.03±3.69,73.23±3.5

The mean diastolic blood pressure of the dexmedetomidine group after

extubation at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are

77.70±4.49, 75.50±4.61, 73.23±5.18, 71.95±5.20, 71.65±5.10,

72.37±4.95,71.80±4.89,71.20±4.56,71.73±4.89,71.53±4.28,71.40±4.17,71.33

(71)

Statistical analysis reveals a P value of diastolic blood pressureafter

extubation at 2,4, 6,8, 10, 25, 40, 55, 70,85,100,115, 130 minutes as 0.000,

0.000, 0.000, 0.000, 0.000, 0.000, 0.000,0.000,0.000,0.000,0.000, 0.002,

0.021. These P values are statistically significant.

The mean difference of diastolic blood pressure between

dexmedetomidine and fentanyl groups at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation are

0.7,0.75,-0.57,-1.28.

Statistical analysis reveals a P value for the mean difference of diastolic

blood pressure between dexmedetomidine and fentanyl groups at baseline,

after induction and intubation, 10 minutes before extubation, 5 minutes before

extubation are 1.0,1.0,1.0,0.840 respectively and hence statistically

insignificant.

The mean difference of diastolic blood pressure between

dexmedetomidine and fentanyl groups during extubation was -1.31. P value

was found to be 0.798 and hence statistically insignificant.

The mean difference of diastolic blood pressure between

(72)

Statistical analysis reveals a P value for the mean difference of diastolic

blood pressure between dexmedetomidine and fentanyl groups after

extubation at 2, 4, 6, 8 minutes as 0.214,0.102,0.084,0.061 respectively and

hence statistically insignificant.

The mean difference of diastolic blood pressure between

dexmedetomidine and fentanyl groups after extubation at 10,25,40, 55, 70, 85,

100,115, 130 minutes are -6.22,-5.40,-4.97,-4.52,-3.20,-3.33,-2.80,-2.70,1.93

respectively and P value for the mean difference of diastolic blood pressure

between dexmedetomidine and fentanyl groups after extubation at 10,25,40,

55, 70, 85, 100,115, 130 minutes are 0.000,

0.000,0.000,0.000,0.001,0.000,0.001,0.001,0.037 respectively , hence

(73)

FIGURE NO.16.DIASTOLIC BLOOD PRESSURE

75.37 96.10

78.35 74.52

98.72

91.85 88.15

84.43 81.60 79.58 79.07

77.30 76.43 75.23 74.97 74.43 73.27 73.08 74.87

96.97

76.83 73.45 81.25 77.70 75.50 73.23 71.95 71.65 72.37 71.80 71.20 71.73 71.53 71.40 71.33 71.30

0.00 20.00 40.00 60.00 80.00 100.00 120.00

Di

as

to

lic

B

P

in

m

m

Hg

Time

DIASTOLIC BLOOD PRESSURE

(74)

MEAN ARTERIAL PRESSURE

TABLE.NO.10. MEAN ARTERIAL PRESSURE

Descriptive

Statisticsa NormalSaline Fentanyl Dexmedetomidine P value

N or m al Sa line Std. D ev ia tio n Fe nta ny l Std. D ev ia tio n D ex m ede to m id ine Std. D ev ia tio n

b_map 92.27 5.25 91.99 5.04 92.49 6.47 0.885

ind_map 113.79 12.63 114.38 8.29 115.23 7.51 0.721

bef_10_map 95.66 4.60 94.63 5.77 94.60 4.57 0.424

bef_5_map 91.68 5.57 91.82 5.22 90.72 6.16 0.017

extu_map 116.83 7.54 100.44 5.22 99.30 6.50 0

aft_map2 109.75 6.60 96.38 6.05 95.12 4.11 0

map4 105.58 4.77 94.02 4.77 92.60 4.00 0

map6 101.53 4.53 91.80 4.46 90.26 5.07 0

map8 98.45 4.43 90.62 4.04 88.94 4.79 0

map10 96.35 3.99 93.94 4.11 88.37 4.69 0

map25 95.87 3.83 93.81 3.77 89.40 4.68 0

map40 94.05 3.58 92.70 3.55 88.75 4.32 0

map55 93.05 3.49 91.92 4.16 88.22 4.06 0

map70 91.95 3.46 91.42 4.04 88.76 3.88 0

map85 91.41 3.64 91.24 3.51 88.45 3.52 0

map100 91.01 3.64 90.63 3.78 88.22 3.03 0

map115 90.06 3.89 90.28 3.38 88.03 2.86 0.001

map130 89.66 3.72 89.66 3.32 87.93 3.44 0.008

The mean values of mean arterial pressure at baseline, during induction

and intubation, before extubation, during extubation and after extubation was

(75)

The mean values of mean arterial pressure at baseline, after induction

and intubation, 10 minutes before extubation, 5 minutes before extubation in

the normal saline group were 92.27±5.25, 113.79±12.63, 95.66±,4.60

91.68±5.57.

The mean values of mean arterial pressure at baseline, after induction

and intubation, 10 minutes before extubation, 5 minutes before extubation in

the fentanyl group were 91.99±5.04, 114.38±8.29,94.63±5.77, 91.82±5.22.

The mean values of mean arterial pressure at baseline, after induction

and intubation, 10 minutes before extubation, 5 minutes before extubation in

the dexmedetomidine group were 92.49±6.47, 115.23 ±7.51, 94.60±4.57,

90.72±6.16.

Statistical analysis showed a P value of mean arterial pressure at

baseline, after induction and intubation, 10 minutes before extubation, 5

minutes before extubation were 0.885, 0.721, 0.424,0.017 hence the mean

values of mean arterial pressure at baseline, after induction and intubation, 10

minutes before extubation between the groups were statistically insignificant

and the mean values of mean arterial pressure 5 minutes before extubation

(76)

The mean values of mean arterial pressure during extubation in the

normal saline group was116.83 ±7.54, in the Fentanyl group was100.44±5.22,

in the dexmedetomidine group was 99.30 ±6.50.

Statistical analysis showed a P value of mean arterial pressureduring

extubation was 0.000 and hence statistically significant.

The mean values of mean arterial pressure of the normal saline group

after extubation at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are109.75

±6.60, 105.58 ±4.77,101.53 ±4.53, 98.45 ±4.43, 96.35 ±3.99, 95.87±3.83,

94.05 ±3.58, 93.05±3.49, 91.95±3.46, 91.41 ±3.64, 91.01±3.64, 90.06±3.89,

89.66 ±3.72.

The mean values of mean arterial pressureof the fentanyl group after

extubation at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are 96.38

±6.05, 94.02±4.77, 91.80±4.46, 90.62±4.04, 93.94±4.11, 93.81±3.77,

92.70±3.55, 91.92±4.16, 91.42±4.04,91.24±3.51, 90.63±3.78, 90.28 ±3.38,

89.66 ±3.32.

The mean values of mean arterial pressure of the dexmedetomidine

group after extubation at 2,4,6,8,10,25,40,55,70,85,100,115, 130 minutes are

(77)

88.75±4.89, 88.22±4.56, 88.76±4.89,88.45±4.28,88.22 ±4.17,88.03 ±3.84,

87.93 ±4.21.

Statistical analysis reveals a P value of mean arterial pressureafter

extubation at 2,4, 6,8, 10, 25, 40, 55, 70,85,100,115, 130 minutes as 0.000,

0.000, 0.000, 0.000, 0.000, 0.000, 0.000,0.000,0.000,0.000,0.000, 0.001,

0.008. These P values are statistically significant.

The mean difference of mean arterial pressure between

dexmedetomidine and fentanyl groups at baseline, after induction and

intubation, 10 minutes before extubation, 5 minutes before extubation are

0.506,0.849,-0.035,-1.096.

Statistical analysis reveals a P value for the mean difference of mean

arterial pressure between dexmedetomidine and fentanyl groups at baseline,

after induction and intubation, 10 minutes before extubation, 5 minutes before

extubation are 1.0,1.0,1.0,0.872 respectively and hence statistically

insignificant.

The mean difference of mean arterial blood pressure between

dexmedetomidine and fentanyl groups during extubation was -1.14. P value

(78)

The mean difference of mean arterial pressure between

dexmedetomidine and fentanyl groups after extubation at 2, 4, 6, 8 minutes

are -1.26,-1.42,-1.54,-1.68 respectively.

Statistical analysis reveals a P value for the mean difference of mean

arterial blood pressure between dexmedetomidine and fentanyl groups after

extubation at 2, 4, 6, 8 minutes as 0.702,0.543,0.235,0.082 respectively and

hence statistically insignificant.

The mean difference of mean arterial blood pressure between

dexmedetomidine and fentanyl groups after extubation at 10,25,40, 55, 70, 85,

100,115, 130 minutes are -5.57,-4.41,-3.95,-3.69,-2.66,-2.80,-2.42,-2.24, -1.73

and P value for the mean difference of mean arterial pressure between

dexmedetomidine and fentanyl groups after extubation at 10,25,40, 55, 70, 85,

100,115, 130 minutes are 0.000,

0.000,0.000,0.000,0.001,0.000,0.001,0.001,0.022 respectively , hence

(79)

FIGURE NO.17.MEAN ARTERIAL PRESSURE

91.99 114.38

94.63 91.82 101.04 96.93 93.81 91.03 90.80 93.94 93.81 92.70 91.92 91.42 91.24 90.63 90.28 89.66

0.00 20.00 40.00 60.00 80.00 100.00 120.00 140.00

M

ean

ar

te

rial

p

re

ss

ur

e

in

m

m

Hg

Time

MEAN ARTERIAL PRESSURE

(80)

SP02

TABLE NO.11. SPO2

Normal

Saline Fentanyl Dexmedetomidine P value

N or m al Sa line Std. D ev ia tio n Fe nta ny l Std. D ev ia tio n D ex m ede to m id ine Std. D ev ia tio n

base_spo2 99.93 0.36 99.93 0.52 99.98 0.13 0.697

indu_spo2 100.00 0.00 100.00 0.00 100.00 0.00

-bef_ex_10 100.00 0.00 100.00 0.00 100.00 0.00

-bef_ex_5 100.00 0.00 100.00 0.00 100.00 0.00

-during_ex 99.97 0.26 99.87 0.81 99.98 0.13 0.383

aft_2 99.92 0.46 99.88 0.67 99.93 0.36 0.863

aft_4 99.90 0.48 99.88 0.78 99.85 0.68 0.915

aft_6 99.85 0.58 99.82 0.93 99.78 0.90 0.906

aft_8 99.85 0.71 99.82 0.83 99.75 1.00 0.809

aft_10 99.82 0.72 99.87 0.60 99.78 0.90 0.830

aft_25 99.65 0.97 99.63 0.99 99.78 0.76 0.616

aft_40 99.73 0.69 99.65 0.88 99.67 0.97 0.852

aft_55 99.75 0.54 99.75 0.63 99.73 0.88 0.989

aft_70 99.65 0.68 99.60 1.58 99.60 0.74 0.194

aft_85 99.82 0.43 99.70 0.74 99.63 0.94 0.386

aft_100 99.75 0.44 99.75 0.75 99.68 0.72 0.369

aft_115 99.80 0.44 99.80 0.61 99.70 0.81 0.612

aft_130 99.80 0.40 99.77 0.62 99.73 0.78 0.841

From the table, Statistical analysis showed a P value of saturation of

oxygen between normal saline group,fentanyl group, dexmedetomidine group

at all time during the study found to be >0.05 and hence statistically

(81)

FIGURE NO.18 SPO2

99.93 100.00 100.00 100.00 99.87 99.88 99.88 99.82 99.82 99.87

99.63 99.65 99.75 99.60 99.70 99.75 99.80 99.77

98.00 98.50 99.00 99.50 100.00 100.50

SP

02%

Time

SP02

Figure

FIG.NO.1 UPPER RESPIRATORY TRACT
FIG NO 1 UPPER RESPIRATORY TRACT. View in document p.23
FIG. NO. 2. NERVE SUPPLY OF LATERAL WALL OF NOSE
FIG NO 2 NERVE SUPPLY OF LATERAL WALL OF NOSE. View in document p.24
FIG NO.3.NERVE SUPPLY OF MEDIAL WALL OF NASAL CAVITY
FIG NO 3 NERVE SUPPLY OF MEDIAL WALL OF NASAL CAVITY. View in document p.25
FIG.NO.4. NERVE SUPPLY OF MOUTH AND PHARYNX
FIG NO 4 NERVE SUPPLY OF MOUTH AND PHARYNX. View in document p.27
FIG.NO.5. NERVE SUPPLY OF LARYNX
FIG NO 5 NERVE SUPPLY OF LARYNX. View in document p.29
FIG.NO.7. DEXMEDETOMIDINE- ACTIONS IN BRAIN AND BRAIN
FIG NO 7 DEXMEDETOMIDINE ACTIONS IN BRAIN AND BRAIN. View in document p.32
FIG.NO.8. MOLECULAR STRUCTURE OF FENTANYL
FIG NO 8 MOLECULAR STRUCTURE OF FENTANYL. View in document p.35
TABLE NO.1. MODIFIED ALDRETE SCORE
TABLE NO 1 MODIFIED ALDRETE SCORE. View in document p.46
TABLE NO.2.DEMOGRAPHIC PROFILE: AGE DISTRIBUTION
TABLE NO 2 DEMOGRAPHIC PROFILE AGE DISTRIBUTION. View in document p.49
TABLE NO.3. DEMOGRAPHIC DETAILS OF THE STUDY-GENDERDISTRIBUTION
TABLE NO 3 DEMOGRAPHIC DETAILS OF THE STUDY GENDERDISTRIBUTION. View in document p.50
TABLE NO.4.SURGERY DURATION
TABLE NO 4 SURGERY DURATION. View in document p.51
TABLE NO.6. BODY MASS INDEX
TABLE NO 6 BODY MASS INDEX. View in document p.53
FIGURE NO.13.BODY MASS INDEX
FIGURE NO 13 BODY MASS INDEX. View in document p.54
TABLE NO.7.HEART RATE
TABLE NO 7 HEART RATE. View in document p.55
FIGURE NO.14 HEART RATE
FIGURE NO 14 HEART RATE. View in document p.60
TABLE.NO.8.SYSTOLIC BLOOD PRESSURE
TABLE NO 8 SYSTOLIC BLOOD PRESSURE. View in document p.61
FIGURE NO.15.SYSTOLIC BLOOD PRESSURE
FIGURE NO 15 SYSTOLIC BLOOD PRESSURE. View in document p.67
TABLE.NO.9 DIASTOLIC BLOOD PRESSURE
TABLE NO 9 DIASTOLIC BLOOD PRESSURE. View in document p.68
FIGURE NO.16.DIASTOLIC BLOOD PRESSURE
FIGURE NO 16 DIASTOLIC BLOOD PRESSURE. View in document p.73
TABLE.NO.10. MEAN ARTERIAL PRESSURE
TABLE NO 10 MEAN ARTERIAL PRESSURE. View in document p.74
FIGURE NO.17.MEAN ARTERIAL PRESSURE
FIGURE NO 17 MEAN ARTERIAL PRESSURE. View in document p.79
TABLE NO.11. SPO2
TABLE NO 11 SPO2. View in document p.80
FIGURE NO.18 SPO2
FIGURE NO 18 SPO2. View in document p.81
TABLE NO.12. EXTUBATION QUALITY SCORE
TABLE NO 12 EXTUBATION QUALITY SCORE. View in document p.82
FIGURE NO.19. EXTUBATION QUALITY SCORE
FIGURE NO 19 EXTUBATION QUALITY SCORE. View in document p.83
TABLE NO.13. RAMSAY SEDATION SCORE
TABLE NO 13 RAMSAY SEDATION SCORE. View in document p.84
FIGURE NO.21. BRADYCARDIA
FIGURE NO 21 BRADYCARDIA. View in document p.87
TABLE NO.15. HYPOTENSION
TABLE NO 15 HYPOTENSION. View in document p.88
FIGURE NO.22. HYPOTENSION
FIGURE NO 22 HYPOTENSION. View in document p.89
TABLE.NO.16. VOMITING
TABLE NO 16 VOMITING. View in document p.90

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