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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 SURGERIES”

 

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.

 
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