CTRI Number |
CTRI/2024/03/063501 [Registered on: 04/03/2024] Trial Registered Prospectively |
Last Modified On: |
29/02/2024 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia Preventive |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of the efficacy of IV Dexmedetomidine, Pethidine & Tramadol for prevention of perioperative shivering. |
Scientific Title of Study
|
Comparison of the efficacy of intravenous Dexmedetomidine, Pethidine & Tramadol for prevention of perioperative shivering in patients undergoing spinal anesthesia for Urological Surgeries. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
DEBTANU MAL |
Designation |
POST GRADUATE TRAINEE |
Affiliation |
IQ CITY MEDICAL COLLEGE AND HOSPITAL |
Address |
DEPARTMENT OF ANESTHESIA
IQ CITY MEDICAL COLLEGE & HOSPITAL
SOVAPUR, BIJRA ROAD, JEMUA, B - ZONE, DURGAPUR,
Barddhaman WEST BENGAL 713206 India |
Phone |
08348777720 |
Fax |
|
Email |
maldebtanu@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr SUMEDHA MUKHERJEE |
Designation |
ASSOCIATE PROFESSOR |
Affiliation |
IQ CITY MEDICAL COLLEGE & HOSPITAL |
Address |
DEPARTMENT OF ANAESTHESIOLOGY
IQ CITY MEDICAL COLLEGE & HOSPITAL
Sovapur Bijra Road Jemua B-Zone Durgapur PIN-713206
Barddhaman WEST BENGAL 713206 India |
Phone |
7865985825 |
Fax |
|
Email |
sumedh@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DEBTANU MAL |
Designation |
POST GRADUATE TRAINEE |
Affiliation |
IQ CITY MEDICAL COLLEGE AND HOSPITAL |
Address |
DEPARTMENT OF ANESTHESIA
IQ CITY MEDICAL COLLEGE & HOSPITAL
SOVAPUR, BIJRA ROAD, JEMUA, B - ZONE, DURGAPUR,
Barddhaman WEST BENGAL 713206 India |
Phone |
08348777720 |
Fax |
|
Email |
maldebtanu@gmail.com |
|
Source of Monetary or Material Support
|
IQ CITY MEDICAL COLLEGE HOSPITAL
SOVAPUR, BIJRA ROAD, JEMUA, B - ZONE, DURGAPUR
PIN - 713206 |
|
Primary Sponsor
|
Name |
IQ CITY MEDICAL COLLEGE |
Address |
Department of Anesthesia
Sovapur, Bijra Road, Jemua, B - Zone, Durgapur
PIN - 713206 |
Type of Sponsor |
Private medical college |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Debtanu Mal |
IQ CITY MEDICAL COLLEGE AND HOSPITAL |
Department of Anesthesia
Sovapur, Bijra Road, Jemua, B- Zone , Durgapur
PIN - 713206 Barddhaman WEST BENGAL |
8348777720
maldebtanu@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE , IQ CITY MEDICAL COLLEGE HOSPITAL |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: N209||Urinary calculus, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
INJ Dexmedetomidine |
Drug will be prepared prior in 100 ml NS at dose of 0.5 mcg/kg .After giving Spinal Anesthesia patients will be made to lie in supine position and administered the prepared study drug over 10 minutes. |
Comparator Agent |
INJ Pethidine |
Drug will be prepared prior in 100 ml NS at dose of 0.5 mg/kg .After giving Spinal Anesthesia patients will be made to lie in supine position and administered the prepared study drug over 10 minutes. |
Comparator Agent |
INJ Tramadol |
Drug will be prepared prior in 100 ml NS at dose of 0.5 mg/kg .After giving Spinal Anesthesia patients will be made to lie in supine position and administered the prepared study drug over 10 minutes. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
American Sociey of Anaesthesiologists (ASA) Physical status 1 & 2
Patients posted for Urological Surgery
Undergoing Spinal Anaesthesia |
|
ExclusionCriteria |
Details |
A. Patient refusal
B. Immunocompromised patients
C. Local site infection
D. Known allergy to local Anaesthesia and
study drug
E. Cardio-pulmonary, renal or hepatic
impairment
F. Known history of substance (except tobacco) or
alcohol abuse
G. An initial axillary temp >37.5°c or<35.5°c
H. Blood transfusion during surgery
I. Hypo or hyperthyroidism
J. Convulsion or psychiatric disorder
K. PT (INR) >1.5
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
The present study not only will give us a picture of the efficacy of intravenous Dexmedetomidine, Pethidine, and Tramadol in preventing shivering after spinal anaesthesia in patients undergoing urological surgery. |
At baseline |
|
Secondary Outcome
|
Outcome |
TimePoints |
It will also reflect the intraoperative hemodynamic stability & adverse side effects of the three study drugs. Moreover, it will tell us about patients’ compliance. |
At baseline |
|
Target Sample Size
|
Total Sample Size="105" Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
12/03/2024 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Proposed topic of research:
“COMPARISON
OF THE EFFICACY OF INTRAVENOUS DEXMEDETOMIDINE, PETHIDINE & TRAMADOL FOR
PREVENTION OF PERIOPERATIVE SHIVERING IN PATIENTS UNDERGOING SPINAL ANAESTHESIA
FOR UROLOGICAL SURGERIESâ€
Objectives of proposed research:
GENERAL OBJECTIVE
a)
To compare the efficacy of
intravenous Dexmedetomidine, Pethidine & Tramadol in prevention of peri
operative shivering
SPECIFIC OBJECTIVE
a)
To determine and
compare the efficacy of intravenous Dexmedetomidine, Pethidine & Tramadol
in prevention of perioperative shivering b) To compare the level of
sedation caused by these study drugs c) To determine the adverse
effects (if any) caused by these three drugs
Background
of present study:
Spinal
anaesthesia is widely used as a safe anaesthetic method for both elective and
emergency urological surgeries providing a faster onset and effective motor and
sensory blockade. Shivering is a known complication of spinal anaesthesia. It
occurs in 40 to 70% of patients undergoing surgery under spinal anaesthesia .
Shivering
causes increased metabolism and is associated with marked rise in oxygen
consumption (up to 100 – 600%) of the tissue, thereby causing marked stress on
the circulatory and respiratory systems. It also causes discomfort and
increases surgical pain to the patients. It is associated with increase in
intra-ocular pressure and intra cranial pressure . Shivering
causes adverse peri operative outcomes like wound infection, increased surgical
site bleeding and morbid cardiac events. It may also cause arterial hypoxemia,
lactic acidosis and interfere with pulse rate, blood pressure (BP) and
electrocardiographic (ECG) monitoring .
Various
methods, available to control shivering during anaesthesia, include
non-pharmacological and pharmacological methods. Non-pharmacological methods
using equipment are effective but expensive and lack practicality while drugs
like Pethidine, Tramadol, Clonidine, Dexmedetomidine, Ketamine, Nefopam are
simple, cost-effective and easy to implement.
The
aim of this study is to compare the efficacy, potency, haemodynamic effects,
and side effects of intravenous Dexmedetomidine, Pethidine & Tramadol when
given in pre-emptive dose to control shivering during spinal anaesthesia. We
will further study the efficacy of the above drugs for the treatment of
perioperative shivering
6.Methodology:
An experimental study will be carried out
among patients undergoing urological surgeries in IQ City Medical College &
Hospital in Durgapur, West Bengal. Data will be collected over the 18 months
period. Preoperative evaluation of the patients will be done on the day before
surgery and all of them will be informed about the study. Written and informed
consent will be obtained. On day of surgery, data will be obtained &
statistical analysis will be done with help of appropriate statistical
software.
7.Expected Outcome:
The present study not
only will give us a picture of the efficacy of intravenous Dexmedetomidine, Pethidine,
and Tramadol in preventing shivering after spinal anaesthesia in patients
undergoing urological surgery, but will also reflect the intraoperative
hemodynamic stability and adverse side effects of the three study drugs.
Moreover, it will tell us about patients’ compliance. |