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
|
|
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
|
|
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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