This document describes a research study protocol to evaluate the efficacy of intrathecal dexmedetomidine as an adjuvant to levobupivacaine spinal anesthesia for abdominal hysterectomy. The study will randomly assign 104 patients to receive either levobupivacaine with normal saline or levobupivacaine with 10 μg dexmedetomidine intrathecally. The primary outcomes will be postoperative analgesia duration measured by VAS scores and time to first rescue analgesic. Secondary outcomes include sensory and motor block durations and any intraoperative hemodynamic changes or side effects. Standard protocols will be followed for preoperative, intraoperative and postoperative care.

1. 1
THE CANDIDATE :Dr. PATIL CHETAN PANJABRAO
ADDRESS :AT POST- DAHIGAON, TAL- YAWAL,
DIST- JALGAON 425302
PRESENT ADDRESS :ROOM No 307,
RESIDENT HOSTEL, TULASI BUILDING,
CPR HOSPITAL CAMPUS,
DASARA CHOWK, KOLHAPUR 416002
NAME OF INSTITUTE :RAJARSHEE CHHATRAPATI SHAHU
MAHARAJ GOVT. MEDICAL COLLEGE,
KOLHAPUR, MAHARASHTRA
COURSE OF STUDY :MD
SUBJECT :ANAESTHESIOLOGY.
DATE OF ADMISSION : 5 MARCH 2022
PERIOD OF TRAINING :3 YEARS
TITLE OF THESIS
TO EVALUATE THE EFFICACY OF DEXMEDETOMIDINE
AS AN INTRATHECAL ADJUVANT TO SPINAL
ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN
ABDOMINAL HYSTERECTOMY

2. 2
FOR SUBMITTING PLAN OF WORK OF RESEARCH PROJECT
1)Title of Research Project:
"TO EVALUATE THE EFFICACY OF DEXMEDETOMIDINE AS
AN INTRATHECAL ADJUVANT TO SPINAL ANAESTHESIA
FOR POST OPERATIVE ANALGESIA IN ABDOMINAL
HYSTERECTOMY”
2)Name & Designation of:
a. Post Graduate Guide: DR. MARUTI PAWAR
ASSOCIATE PROFESSOR,
DEPT. OF ANAESTHESIOLOGY,
RAJARSHEE CHHATRAPATI SHAHU MAHARAJ
GOVERNMENT MEDICAL COLLEGE
. KOLHAPUR.
b. Post Graduate Student: Dr. PATIL CHETAN PANJABRAO
MD TRAINEE IN ANAESTHESIOLOGY
RAJARSHEE CHHATRAPATI SHAHU MAHARAJ
GOVERNMENT MEDICAL COLLEGE
KOLHAPUR.
3)Duration of Research Project: 2 Years
a.Period which may be needed: January 2023 to December
for collection of data 2023
b. Deadline for collecting data: December 2023
c. Period that may be required for analysing the data: January 2024
. to July 2024
d. Deadline for analyzing the data: July 2024

3. 3
4)Review of progress of the Research project: Every 3 months
a. Review of collected data date: 31 December 2023
b. Review of analysing data date: 31 July 2024
5)Date of Registration:
6) Date of appearing for Examination:
7)Signature:
a. Post Graduate Student:
b. Post Graduate guide:
c. Head of Dept. of concerned subject:
d. Head of Dept. of supporting subject:
e. Remarks and signature of secretory
of Ethical committee:
APPROVED / DISAPPROVED
DATE: PLACE:KOLHAPUR.

4. 4
INDEX
SR.NO. CONTENT
1 INTRODUCTION
2 REVIEW OF LITERATURE
3 AIMS AND OBJECTIVES
4 MATERIAL AND METHODS
5 REFERENCES
6 ANNEXURE
6.1 STUDY PROFORMA
6.3 INFORMED CONSENT FORM
7 APPROVAL OF ETHICAL COMMITTEE
AND IT’S COMPOSITION
8 APPROVAL OF SCIENTIFIC COMMITTEE
AND IT’S COMPOSITION

5. 5
INTRODUCTION
Pain after gynaecological surgeries is often underrated as it is assumed
to be associated with lower pain intensity. This under treatment of pain
leads to patient dissatisfaction and other complications. The patient
mobility, length of hospital stay and recovery can be hastened by using
different analgesic methods. Different modalities of pain management
have been effectively used and compared with each other.
Abdominal Hysterectomy is one of the most common surgical
procedures performed and post‑operative pain associated with it may be
moderate to severe. It is associated with delayed return to normal daily
activities and may also be related to persistent post‑surgical pain . The
major goal in the management of post‑operative pain is minimizing the
dose of medications to lessen side effects while still providing adequate
analgesia. Various modalities available to control pain after surgery
include pharmacological methods, topical analgesics, regional nerve
block techniques. They offer a great degree of post‑operative pain relief
thus facilitating early ambulation and discharge. Among these
modalities regional anaesthetic techniques have proven to be superior in
providing satisfactory pain control.
One of the basic reasons to add neuraxial adjuvant drugs to intrathecal
(IT) or spinal heavy levobupivacaine is to prolong the duration of
sensory block thereby providing an extended postoperative pain relief.
Our clinical experience suggests that patients undergoing any surgical
procedures on uterus usually experience a mild to moderate degree of
pain in the immediate postoperative period. This type of pain is usually
poorly localized visceral pain and adds to more discomfort than
pain to the patient. As most of these procedures are done under spinal
anaesthesia, adding a neuraxial adjuvant not only prolongs the duration

6. 6
of postoperative analgesia but is also effective in attenuating this poorly
localized visceral pain.
A number of adjuvants have been added to local anesthetic agents for
subarachnoid block to prolong the intra and post operative analgesia.
Nonetheless, agents such as clonidine, midazolam, opioids, and
neostigmine are associated with varying side effects profile.Opioids are
commonly used adjuvant, they produce rapid onset and good quality of
surgical block but with side effects such as pruritus, nausea, and
vomiting. These prompted further search toward non opioid analgesic.
Dexmedetomidine an α2–adrenergic receptor agonist
which causes anxiolysis, sedation, analgesia and is sympatholytic with
minimal respiratory depression but prolongs the postoperative analgesic
effect with minimal side effects. However, there is a paucity of reports
in our environment. This study seeks to validate the postoperative
analgesic effect produced by intrathecal administration of
dexmedetomidine with levobupivacaine for Abdominal Hysterectomies.

7. REVIEW OF LITERATURE
Minagar M et al. [1] conducted a study to evaluate effects of adding
Dexmedetomidine to hyperbaric bupivacaine in lower abdominal
surgeries under spinal anaesthesia. Main outcomes were considered
pain score, duration of analgesia, hemodynamic changes and adverse
side effects like nausea and vomiting. 50 person receive 12.5 mg
hyperbaric bupivacaine + 5 µg dexmedetomidine intrathecally while 50
person receive 12.5 mg hyperbaric bupivacaine + 0.5 cc Normal Saline
intrathecally. The study concluded that intrathecal dexmedetomidine
increases duration of analgesia and reduces post operative pain without
changes in hemodynamic parameters and adverse side effects.
Gupta R et al. [2] conducted a study aimed to determine efficacy and
safety of intrathecal dexmedetomidine added to ropivacaine. Sixty
patients were randomly allocated to receive intrathecally either 3 ml of
0.75% isobaric ropivacaine + 0.5 ml normal saline (Group R) or 3 ml of
0.75% isobaric ropivacaine + 5 μg dexmedetomidine in 0.5 ml of
normal saline (Group D). The mean time of sensory regression to S2
was 468.3±36.78 minutes in group D and 239.33±16.8 minutes in group
R. Duration of analgesia (time to requirement of first rescue analgesic)
was significantly prolonged in group D (478.4±20.9 minutes) as
compared to group R (241.67±21.67 minutes). The maximum visual
analogue scale score for pain was less in group D (4.4±1.4) as compared
to group R (6.8±2.2). The study concluded that addition of
dexmedetomidine to ropivacaine intrathecally produces a prolongation
in the duration of the motor and sensory block.
Farokhmehr L et al. [3] studied the effect of different doses of
intrathecal dexmedetomidine on hemodynamic parameters and block
characteristics after ropivacaine spinal anesthesia in lower-limb
orthopedic surgery. In a double-blind trial, 90 patients unundergoing
spinal anesthesia for lower-limb orthopedic surgery were included and
then randomly assigned to three groups;

8. 8
dexmedetomidine 5 μg/kg, dexmedetomidine 10 μg/kg and placebo.
Blood pressure, heart rate, and oxygen saturation were recorded in
the three groups at the first 15 minutes and then every 15 to 180
minutes at recovery by a resident anesthesiologist, as well as
sensory-motor block onset. The visual analog scale scores for the
assessment of pain were recorded at recovery, and 2, 4, 6, and 12
hours postoperatively. The Bromage score was higher in the 10
μg/kg dexmedetomidine group (P = 0.0001) with lower pain score as
compared with the 5 μg/kg dexmedetomidine and placebo groups (P
= 0.0001). Therefore, an increase in dexmedetomidine hastens the
onset of sensory-motor block but not causes side effects.
Khosravi F et al. [4] did a Comparative Study of Fentanyl vs
Dexmedetomidine as Adjuvants to Intrathecal Bupivacaine in
Cesarean Section. This study involved 110 pregnant women with
ASA I and II and gestational age ≥37 weeks who were candidates for
elective cesarean section. They were randomly divided into two
groups of 55; Group B-D received 10 mg bupivacaine (0.5%) + 5 μg
dexmedetomidine and Group B-F received 10 mg bupivacaine
(0.5%) + 25 μg fentanyl, intrathecally. The onset of block, duration
of analgesia, the score of pain intensity, hemodynamic changes,
Apgar scores, and any adverse events were evaluated. P-value <0.05
was considered statistically significant. It concluded that compared
with fentanyl, it seems that adding 5 μg dexmedetomidine to
bupivacaine has a better effect on postoperative pain management in
cesarean section under spinal anesthesia.
Shukla U et al. [5] did a clinical comparison with Dexmedetomidine
versus midazolam as adjuvants to intrathecal bupivacaine. A total of
80 patients, scheduled for vaginal hysterectomies, were randomly
allocated to Group D (n = 40) to receive intrathecally 3.0 mL 0.5%

9. hyperbaric bupivacaine +5 ug dexmedetomidine in 0.5 mL of normal
saline; and Group M (n = 40) to receive 3 mL of 0.5% hyperbaric
bupivacaine +2 mg midazolam in 0.4 mL (5 mg/mL) +0.1 mL
normal saline. The onset, duration of sensory and motor block, time
to first postoperative analgesia and side effects were noted. The
study concluded intrathecal dexmedetomidine was better adjuvant
than midazolam as it produces significantly longer duration of
sensory block, reduced doses of postoperative analgesic agents with
comparable side-effects.
Gupta M et al. [6] studied effect of 3 Different Doses of Intrathecal
Dexmedetomidine (2.5µg, 5µg, and 10 µg) on Subarachnoid Block
Characteristics. To elucidate the dose-response relationship between
ITD and subarachnoid block characteristics, particularly the duration
of analgesia and differential analgesia (DA: defined as time
difference from the offset of motor blockade to the first analgesic
requirement on numerical rating scale = 4.0). Ninety adult (18 - 60
years) patients undergoing elective lower abdominal and lower limb
surgeries were randomized into 3 groups to receive intrathecal 0.5%
bupivacaine 3 mL with 2.5 µg (group BD2.5), 5µg (group BD5), or
10 µg (group BD10) dexmedetomidine in 0.5 mL normal saline. The
2 segment sensory regression times (TSSRT), duration of motor
blockade analgesia, DA, and perioperative adverse effects were
assessed. The study concluded that the addition of 10 µg compared
with 2.5 µg or 5µg ITD to 0.5% hyperbaric bupivacaine is associated
with significantly earlier onset of sensory and motor block as well as
prolonged duration of sensory block, motor block, analgesia, and DA
with a comparable adverse effect profile.

10. 10
AIMS AND OBJECTIVES
Aim : To evaluate the efficacy of intrathecal Dexmedetomidine as an
adjuvant to Levobupivacaine in spinal anaesthesia in patients
undergoing Abdominal Hysterectomy.
Objectives: 1. To evaluate the duration of analgesia post operatively
using Visual Analogue Scale (VAS).
2. To evaluate total duration of sensory and motor
block.
3. To evaluate intra operative hemodynamic changes
and side effects.

11. Material and Methods
Study Area
Department of Anesthesiology of a tertiary care hospital.
Study Population
All female patients undergoing Abdominal Hysterectomy in our
hospital.
Sample Size
Sample size was determined by using the effect sizes from previously
published study by using this formula.
[Z1-α/2√{2P(100-P)} + Z 1-β√{P1(100-P1)+P2(100-P2)}]²
P1-P2
where,
n - sample size
z - normal deviant at the portion of 95% confidence
interval = 1.96
p – prevalence value of post operative pain in Abdominal
Hysterectomy (92.7%)
With prevalence of post operative pain 92.7% and 5% absolute error, at
95% confidence interval sample size is 104.
Study Design
A Randomized control study
Study Duration
2 Years

12. INCLUSION CRITERIA
1. Patients willing to participate in study
2. Patients with age between 18-65 years and who belong to American
Society of Anaesthesiologists (ASA) physical status grade I and II.
3. Patients posted for Abdominal Hysterectomy.
EXCLUSION CRITERIA
1. Patients refusal.
2. Those with contraindication to spinal anaesthesia.
3. ASA status grade III and IV.
4. Allergy to local anaesthetic or adjuvant medication.
5. Patients with bleeding diathesis or coagulopathy.
6. Local infection at the site of subarachanoid block.
7. Patient requiring other stronger analgesics other than injection
Tramadol within 24 hr.

13. Methodology
A.After approval of institutional ethical committee and taking written
informed consent from the participating patients, the patients will be
randomly allocated to 2 groups (Group I and Group II) of 52 each.
Group I will receive 3 ml of 0.5% Hyperbaric Levobupivacaine (15
mg) and 0.5 ml normal saline (total 3.5ml). Group II will receive 3
ml of 0.5% Hyperbaric Levobupivacaine (15 mg) with 10 μg
Dexemedetomidine made up to 0.5 ml with normal saline (total 3.5
ml).
B. Standard pre-operative, intra-operative and post-operative
protocols will be followed.
C. During the pre-anaesthetic check-up patients will be explained
about VAS and the level of analgesia in the postoperative period
will be recorded with score 0 indicating no pain and 10 indicating
severe pain.Baseline parameters like pulse, blood pressure; ECG
will be measured before the surgical procedure. Intravenous line
will be secured and patients preloaded with Ringer’s lactate 10
ml/kg body weight over 20 to 30 minutes.
D.All spinal blocks will be administered with patient in sitting position
using the midline approach at L2-3 or L3-L4 vertebral interspaces.
Skin infiltration will be done by raising a wheal with 0.5ml of 2%
Lignocaine plain. The subarachnoid space will be entered using a
25-gauze Quincke’s spinal needle. Once free flow of Cerebrospinal
fluid is recognized, the intrathecal anaesthetic solution in a
standardized dose will be injected over 20 seconds. Group I will
receive 3 ml of 0.5% Hyperbaric Levobupivacaine (15 mg) and 0.5
ml normal saline (total 3.5ml). Group II will receive 3 ml of 0.5%
Hyperbaric Levobupivacaine (15 mg) with 10 μg
Dexemedetomidine made up to 0.5 ml with normal saline (total 3.5
ml).Immediately following the injection, patients will be made to lie

14. in the supine position. Continuous monitoring of hemodynamic
parameters will be done and readings will be recorded every 5
minutes for first 30 minutes, thereafter every 10 minutes till the end
of surgery.
E. The onset of sensory block will be tested by ‘pin-prick method’
using a hypodermic needle at 2 minutes interval. The time of
onset will be taken from the time of injection of drug into
subarachnoid space to loss of pinprick sensation. The highest
level of sensory block, duration of sensory blockade taken as
time from onset to time of return of pinprick sensation to
S1(heel) dermatomal area will be noted. VAS will be recorded at
an interval of 0,0.5, 1,2,4,6,8,12,24 hours postoperatively.
Duration of complete analgesia will be noted and rescue
analgesics will be given to the patients when VAS ≥4. The cutoff
point of our study will be the time when the patient demand the
first dose of rescue analgesia.
F. The onset of motor block will be assessed with ‘Modified
Bromage Score’. The time interval between injections of drug
into subarachnoid space, to the patient’s inability to lift the
straight extended leg will be taken as onset time (Bromage 3).
The duration of motor block will be taken from time of injection
to complete regression of motor block (ability to lift the
extended leg) (Bromage 0).
Modified Bromage Scale :-
• Grade0- Full flexion of knees and feet.
• Grade1- Just able to flex knees, full flexion of feet.
• Grade2- Unable to flex knees, but some flexion of feet possible.
• Grade3- Unable to move legs or feet.

15. G. Side effects like sedation, nausea, vomiting, shivering will be
monitored in the recovery room and then patient shift to the ward.
H. The patients will receive tramadol 2 mg/kg IV if VAS ≥4 in the
first 4 h after the surgery. For persistent VAS ≥4 in this period,
diclofenac 75 mg IV will be administered. After 4 h, patients will be
administered oral diclofenac 75 mg if VAS ≥4. Injection
ondansetron (4 mg) IV will be given for post‑operative nausea and
vomiting. Post operative analgesia and total analgesic consumption
in the 24 h postoperative period will be the primary objective of the
study.
I. The patients will be interviewed at 0, 0.5, 1, 2, 4, 6, 8, 12 and 24 Hr
after surgery. VAS scores at rest and at knee flexion, duration after
which first analgesic was demanded by the patient, incidence of
nausea, vomiting as well as the overall patient satisfaction will also
be observed.
J. The data will be entered using Microsoft excel sheet and will be
analysed using Statistical Package for Social Sciences (SPSS)
version 22.0 software (IBM Corp. Released 2011. IBM SPSS
Statistics for windows, Version 20.0. Armonk, NY: IBM Corp.).
Catagorical data will be presented in form of frequency and
proportion. as test of significance for qualitative data inform of
frequency and proportion. Chi‑square test will be used as test of
significance for qualitative data.Continous data like VAS score will
be analysed using mean and standard deviation and Mann-Whitney
U test A probability of P < 0.05 will considered statistically
significant.

16. References
[1] Nwachukwu C, Idehen HO, Edomwonyi NP, Umeh B.
Postoperative analgesic effect of intrathecal dexmedetomidine on
bupivacaine subarachnoid block for open reduction and internal
fixation of femoral fractures. Niger J ClinPract. 2020 Feb;23(2):172-
178. doi: 10.4103/njcp.njcp_142_19. PMID: 32031091
[2] Minagar M, Alijanpour E, Jabbari A, Rabiee SM, Banihashem N,
Amri P, Mir M, HedayatiGoodarzi MT, Esmaili M. The efficacy of
addition of dexmedetomidine to intrathecal bupivacaine in lower
abdominal surgery under spinal anesthesia. Caspian J Intern Med.
2019 Spring;10(2):142-149. doi: 10.22088/cjim.10.2.142. PMID:
31363392; PMCID: PMC6619478.
[3] Patro SS, Deshmukh H, Ramani YR, Das G. Evaluation of
Dexmedetomidine as an Adjuvant to Intrathecal Bupivacaine in
Infraumbilical Surgeries. J ClinDiagn Res. 2016 Mar;10(3):UC13-6.
doi: 10.7860/JCDR/2016/17987.7379. Epub 2016 Mar 1. PMID:
27134975; PMCID: PMC4843360.
[4] Gupta R, Bogra J, Verma R, Kohli M, Kushwaha JK, Kumar S.
Dexmedetomidine as an intrathecal adjuvant for postoperative
analgesia. Indian J Anaesth. 2011 Jul;55(4):347-51. doi:
10.4103/0019-5049.84841. PMID: 22013249; PMCID:
PMC3190507.
[5] Farokhmehr L, Modir H, Yazdi B, Kamali A, Almasi-Hashiani A.
Effect of different doses of intrathecal dexmedetomidine on
hemodynamic parameters and block characteristics after ropivacaine
spinal anesthesia in lower-limb orthopedic surgery: a randomized
clinical trial. Med Gas Res. 2019 Apr-Jun;9(2):55-61. doi:
10.4103/2045-9912.260645. PMID: 31249252; PMCID:
PMC6607861.
[6] Khosravi F, Sharifi M, Jarineshin H. Comparative Study of
Fentanyl vs Dexmedetomidine as Adjuvants to Intrathecal
Bupivacaine in Cesarean Section: A Randomized, Double-Blind

17. Clinical Trial. J Pain Res. 2020 Oct 7;13:2475-2482. doi:
10.2147/JPR.S265161. PMID: 33116789; PMCID: PMC7548853.
[7] Shukla U, Prabhakar T, Malhotra K, Srivastava D.
Dexmedetomidine versus midazolam as adjuvants to intrathecal
bupivacaine: A clinical comparison. J AnaesthesiolClinPharmacol.
2016 Apr-Jun;32(2):214-9. doi: 10.4103/0970-9185.182105. PMID:
27275052; PMCID: PMC4874077.
[8] Gautam B, Niroula S, Sharma M, Lama SM. Effects of Intrathecal
Dexmedetomidine as an Adjuvant to Hyperbaric Bupivacaine for
Spinal Anaesthesia in Adults Undergoing Elective Infra-umbilical
Surgery. JNMA J Nepal Med Assoc. 2017 Oct-Dec;56(208):379-87.
PMID: 29453466.
[9] Kapinegowda ST, Anandswamy TC, Narayanappa VH, Kumar S,
Hatti P. To Compare the Effects of Different Doses of
Dexmedetomidine on Intrathecal Bupivacaine in Infraumbilical
Surgeries: A Prospective, Randomized, Double-blind Clinical Study.
Anesth Essays Res. 2017 Oct-Dec;11(4):847-853. doi:
10.4103/aer.AER_257_16. PMID: 29284837; PMCID:
PMC5735476.
[10] Naaz S, Bandey J, Ozair E, Asghar A. Optimal Dose of Intrathecal
Dexmedetomidine in Lower Abdominal Surgeries in Average Indian
Adult. J ClinDiagn Res. 2016 Apr;10(4):UC09-13. doi:
10.7860/JCDR/2016/18008.7611. Epub 2016 Apr 1. PMID:
27190922; PMCID: PMC4866220.
[11] Gupta M, Gupta P, Singh DK. Effect of 3 Different Doses of
Intrathecal Dexmedetomidine (2.5µg, 5µg, and 10 µg) on
Subarachnoid Block Characteristics: A Prospective Randomized
Double Blind Dose-Response Trial. Pain Physician. 2016
Mar;19(3):E411-20. PMID: 27008297.
[12] Singh A, Gupta A, Datta PK, Pandey M. Intrathecal
levobupivacaine versus bupivacaine for inguinal hernia surgery: a
randomized controlled trial. Korean J Anesthesiol. 2018

18. Jun;71(3):220-225. doi: 10.4097/kja.d.18.27191. Epub 2018 Apr 24.
PMID: 29684982; PMCID: PMC5995016.
[13] Afonso J, Reis F. Dexmedetomidine: current role in anesthesia and
intensive care. Rev Bras Anestesiol. 2012 Jan-Feb;62(1):118-33. doi:
10.1016/S0034-7094(12)70110-1. PMID: 22248773.
[14] C Paul, G Barasch, Bruce F Collen. Clinical Anaesthesia, 6th
edition, Lippincort, Williams and Wilkins, 2006:700-706.

19. ANNEXURE
CASE RECORD PROFORMA
“TO EVALUATE THE EFFICACY OF DEXMEDETOMIDINE AS AN INTRATHECAL
ADJUVANT TO SPINAL ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN
ABDOMINAL HYSTERECTOMY”
DEMOGRAPHIC DATA : Date-
Group A / B
Name-
Age- Yrs Weight- Kgs Blood Group-
Adm. No.
PREOP ASSESSMENT-
Pulse- /min BP- mm Hg
Hb- gm% TLC- /cu mm
DLC- P- L- M- E-
Urine R/M- Any other-
ASA physical status- Emergency-Yes/No
Time of Spinal anaesthesia –
Time of start of surgery -
Level of anaesthesia achieved -
Time for loss of pin prick sensation in S1-
Time for return of pin prick sensation in S1-
Time for Modified Bromage Scale Grade 3-
Time for return of Modified Bromage Scale Grade 0-

20. Vas at rest 0 min 30 min 60 min 2h 4h 6h 8h 12h 24h
Group I
P
Group II
P*
P**
P=value calculated using Mann-whitney test *P value compared with the
baseline of the same group **Pvalue comparing both the groups with each other.
Time of completion of surgery-
HR BP VAS
Score
Analgesic
dose
Analgesic
time
Post
op
2
4
6
8
12
24

21. Time to first dose of Tramadol (from spinal anesthesia) –
Total dose of Tramadol and diclofenac in 24 hrs-
COMPLICATIONS -
Drowsiness
Nausea
Vomiting
Pruritus
Any Other

22. CONSENT FORM
Subject Identification number for this trial -
Title of the project: “ TO EVALUATE THE EFFICACY OF
DEXMEDETOMIDINE AS AN INTRATHECAL ADJUVANT TO SPINAL
ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN ABDOMINAL
HYSTERECTOMY”
Name of the principal investigator: DR. . PATIL CHETAN PANJABRAO
Tel No:
Name: -
Age: - Sex: -
Address: -
I, the undersigned have been duly informed regarding the study undertaken by research trainee
Dr.PATIL CHETAN PANJABRAO, his research guide in above said study is Dr. MARUTI PAWAR.
The study will be conducted in R.C.S.M., Government Medical College &ChhatrapatiPramilaraje
Hospital Kolhapur.All the investigations pertaining to my diagnosis will be conducted with my due
consent. The information obtained or used will be maintained confidential. For academic and scientific
purpose, the operation / procedure may be televised or photographed
At any juncture, I can withdraw from the study without any prior intimation.
I am duly informed and agree to participate in this study.
During this study period if any health complaint arises I will consult Dr. PATIL CHETAN PANJABRAO
Everything is explained to me in my regional language and I have understood it.
Signature of Relative: - Signature of Patient: -
Relatives Name: - Patients Name: -
Relation: - Witnesses:

23. INFORMED CONSENT IN MARATHI
रुग्ण माहिती पूणण संमतीपत्र
“TO EVALUATE THE EFFICACY OF DEXMEDETOMIDINE AS AN INTRATHECAL ADJUVANT TO SPINAL
ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN ABDOMINAL HYSTERECTOMY”
रुग्णाचे नाव:
वय:
ल ंग:
रुग्णा याचे नाव:
नोंदणी क्रमांक:
डॉक्टरांचे नाव:
मी, खा ी सिी/अंगठा करणार श्री/श्रीमती ............................................. या पत्राद्वारे स्वत:च्या जबाबदारी वर
“TO EVALUATE THE EFFICACY OF DEXMEDETOMIDINE AS AN INTRATHECAL ADJUVANT TO SPINAL
ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN ABDOMINAL HYSTERECTOMY”
“या हवषयाच्या वैद्यकीय अभ्यासासाठी संमती देत आिे
या अभ्यासाच्या स्वरुपाची म ा डॉक्टरांनी पूणण कल्पना दद ी आिे व माझ्या सवण शंकाचे समाधानकारक हनरसन के े आिे
म ा माहित आिे दक या अभ्यासादरम्यान मी कुठल्यािी क्षणी, कुणा ािी न सांगता िा अभ्यास सोडून जाण्याचा ककंवा
सिभागीण िोण्याचा िक्क म ा आिे.
माझा आजार, माझ्यावर करण्यात येणार औषधौउपचार आहण तपासण्या इत्याकदंची माहिती संशोधनासाठी वापरण्यास
माझी संमती आिे, असे करताना माझी ओळख आहण वैद्यकीय माहिती गोपनीय रािी असे मी गृिीत धरतो/धरते
रुग्णाची सिी / अंगठा: ददनांक :
साक्षीदाराची सिी: ददनांक:
मी वरी अभ्यासाचे स्वरूप, उद्देश आहण त्याचे दुष्पररणामयांची संपूणण माहिती रुग्णास दद ी आिे.
डॉक्टरांची सिी: ददनांक
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24. UNDERTAKING BY THE INVESTIGATOR
For submission of Research proposal to Ethics Committee of R.C.S.M GMC & C.P.R
Hospital Kolhapur
1] Full name-DR. PATIL CHETAN PANJABRAO
Address - Department Of
Anaesthesiology,
RCSM,GMC&CPR
Hospital Kolhapur
2] Name and address of the medical college, hospital or other facility where the
clinical trial will be conducted:
RCSM, GMC & CPR Hospital Kolhapur
3] Name and address of all clinical laboratory facilities to be used in the study:
4] Name and address of all clinical laboratory facilities to be used in the study:
5] Name and address of the Ethics Committee that is responsible for approval
and continuing review of the study.
Institutional Ethics Committee,
R.C.S.M GMC & C.P.R Hospital Kolhapur
6] Names of the other members of the research team (Co-or sub-Investigators)
who will be assisting the Investigator in the conduct of the investigation(s):
DR. MARUTI PAWAR
Associate Professor
Department of Anaesthesiology,
RCSM GMC& CPR Hospital Kolhapur

25. 7] Protocol Title and study number (if any) of the clinical trial to be conducted by
the Investigator. : “TO EVALUATE THE EFFICACY OF
DEXMEDETOMIDINE AS AN INTRATHECAL ADJUVANT TO SPINAL
ANAESTHESIA FOR POST OPERATIVE ANALGESIA IN
ABDOMINAL HYSTERECTOMY”
NUMBER OF CASES WILL BE: 104
8] Commitments
i. I have reviewed the clinical protocol and agree that it contains all the
necessary information to conduct the study. I will not begin the study until
all necessary Ethics Committee and regulatory approvals have been
obtained.
ii. I agree to conduct the study in accordance with the current protocol. I
will not implement any deviation from or changes of the protocol without
agreement by the Sponsor and prior review and documented
approval/favourable opinion from the Ethics Committee of the amendment,
except where necessary to eliminate an immediatehazard(s) to the trial
Subjects or when the change(s) involved are only logistical or administrative
in nature. I agree to personally conduct and/or supervise the clinical trial at
my site.
iii. I agree to inform all Subjects that the drugs are being used for
investigational purposes and I will ensure that the requirements relating to
obtaining informed consent and ethics committee review and approval
specified in the GCP guidelines are met.
iv. I agree to report to the Sponsor all adverse experiences that occur in the
course of the investigation(s) in accordance with the regulatory and GCP
guidelines.
v. I have read and understood the information in the Investigator’s
broacher, including the potential risks and side effects of the drug.
vi. I agree to ensure that all associates, colleagues and employees assisting in
the conduct of the study are suitably qualified and experienced and they

26. have been informed about their obligations in meeting their commitments in
the trial.
vii. I agree to maintain adequate and accurate records and to make those
records available for audit/inspection by the Sponsor, Ethics Committee,
Licensing Authority or their authorized representatives, in accordance with
regulatory and GCP provisions; I will fully cooperate with any study related
audit conducted by regulatory officials or authorized representatives of the
Sponsor.
viii. I agree to promptly report to the Ethics Committee all changes in the
clinical trial
activities and all unanticipated problems involving risks to human subjects
or others.
ix. I agree to inform all unexpected serious adverse events to the Sponsor as
well as the Ethics Committee within seven days of their occurrence.
x. I will maintain confidentiality of the identification of all participating
study patients and assure security and confidentiality of study data.
xi. I agree to comply with all other requirements, guidelines and statutory
obligations as
applicable to clinical investigators participating in clinical trails.
9] Signature of Investigators with Name and Date :
Principal Investigator : DR PATIL CHETAN PANJABRAO
Co-Investigator : DR MARUTI PAWAR
ASSOCIATE PROFESSOR
DEPARTMENT OF ANAESTHSIOLOGY
R.C.S.M GOVT. MEDICAL COLLEGE CPR
HOSPITAL,KOLHAPUR