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CTRI Number  CTRI/2022/02/039937 [Registered on: 02/02/2022] Trial Registered Prospectively
Last Modified On: 01/02/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to know the efficacy of dexmeditomidine as an anti shivering agent after spinal anaesthesia. 
Scientific Title of Study   A STUDY TO KNOW THE EFFICACY OF DEXMEDETOMIDINE AS AN ANTI SHIVERING AGENT FOLLOWING SPINAL ANAESTHESIA IN ADULTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reema Rajshekhar Wali 
Designation  PostGraduate Resident 
Affiliation  HKE Societys M R Medical College 
Address  Department of Anaesthesiology,Basaveshwar teaching and general hospital

Gulbarga
KARNATAKA
585105
India 
Phone  8867850200  
Fax    
Email  reemawali2@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gajendra Singh 
Designation  Professor 
Affiliation  HKE Societys M R Medical College 
Address  Dept. Of Anaesthesiology, Basaveshwar Teaching and General Hospital

Gulbarga
KARNATAKA
585105
India 
Phone  9886252233  
Fax    
Email  gajendra.glb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gajendra Singh 
Designation  Professor 
Affiliation  HKE Societys M R Medical College 
Address  Dept. Of Anaesthesiology, Basaveshwar Teaching and General Hospital


KARNATAKA
585105
India 
Phone  9886252233  
Fax    
Email  gajendra.glb@gmail.com  
 
Source of Monetary or Material Support  
Basaveshwar Teaching and General Hospital 
 
Primary Sponsor  
Name  Dr Reema Rajshekhar Wali 
Address  642 Double Road Srinagar MM Extension, Belgaum 
Type of Sponsor  Other [Individual] 
 
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 Reema Rajshekhar Wali  Basaveshwar Teaching and General Hospital  Department of Anaesthesiology, Basaveshwar Teaching and General Hospital, Sedam Road
Gulbarga
KARNATAKA 
8867850200

reemawali2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HKE Societys Mahadevappa Rampure Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Post Spinal Shivering 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A - Dexmedetomidine Dose- 1mcg/kg over 20min  Dexmedetomidine is a potent and highly selective α2-adrenoceptor agonist with sympatholytic, sedative, amnestic,6 and analgesic7 properties. Clinical researchers have already studied the administration of dexmedetomidine to prevent shivering. Nevertheless, controversy about the effectiveness of dexmedetomidine for the prevention of shivering is still ongoing, with different results reported in associated literature. In our view, a quantitative analysis on a consolidation of the related data was needed, and therefore, we conducted the present meta-analysis in order to assess the relative merits regarding the anti-shivering effect of dexmedetomidine. 
Comparator Agent  Group B- Placebo  Normal Saline 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA physical status I and II.
2.Age between 18 to 65 years.
3.Patient undergoing surgeries under spinal anaesthesia.
 
 
ExclusionCriteria 
Details  1.Allergic to the study drugs-bupivacaine and dexmedetomidine

2.A Pre-Operative baseline temperature of more than 37.5 degreeCelsius

3.Patients on long standing opioids

4.Patients suffering from thyroid disorders

5.Patient undergoing surgeries like TURP, where irrigation fluids are used
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To study the efficacy of dexmedetomidine in prevention of shivering in adult patients undergoing surgeries under spinal anaesthesia  10 minutes from Time of Spinal Injection to 180 minutes  
 
Secondary Outcome  
Outcome  TimePoints 
To know the side effects of dexmedetomidine  From time of Spinal Injection to 180 minutes 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   07/02/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Spinal anaesthesia is a procedure which is ubiquitous in every healthcare setup. From the day it was described by August Bier in 1898, this technique has undergone many modifications. The management of its complications have  undergone many changes to make it more safer and acceptable. One of the complications which still haunts the anaesthesiologists and thus needs further modifications in its management is shivering.

Shivering is a protective phenomenon which occurs when there is a drop in the core body temperature. As patients plunge into anaesthesia, shivering is always bound to happen and its avoidance is of prime importance.

The main control of temperature in human body is through the hypothalamus, which regulates body temperature between 36.50 to 37.50 Celsius and this is known as inter threshold range1. It is important to maintain this range of temperature for optimal metabolic and physiological functioning and any variations, will lead to derangement of these functions. During any form of anaesthesia there is an imbalance in the body’s ability to generate heat as compared to heat loss. In general anaesthesia use of inhalational anaesthetics, inhibition of autonomic system and behavioral responses makes patient suffer from hypothermia, whereas in spinal anaesthesia there is shift of heat to periphery from core2. Drugs used in treatment of shivering are:Tramadol,Pethidine,nefopam, physostigmine, ketamine, ondansetron, and granisetron3.  

Many trials of dexmedetomidine in prevention of shivering after general anaesthesia have been done, with only few studies of dexmedetomidine in spinal anaesthesia. Hence the present study will be undertaken.

 
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