| CTRI Number |
CTRI/2021/06/034499 [Registered on: 30/06/2021] Trial Registered Prospectively |
| Last Modified On: |
14/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the effect of Dexmedetomidine and Lignocaine in preventing Etomidate-induced Myoclonus |
|
Scientific Title of Study
|
Comparison on the effect of Dexmedetomidine and Lignocaine in the prevention of Etomidate-induced Myoclonus - A Randomized Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shammy N |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Post Graduate Trainee,
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal
Post Graduate Trainee,
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
9895043204 |
| Fax |
|
| Email |
shammynazar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Gojendra Rajkumar |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal 795004, Manipur
Nil
Imphal West
MANIPUR
795004
India |
| Phone |
9862824562 |
| Fax |
|
| Email |
gojendrar68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Gojendra Rajkumar |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Lamphelpat, Imphal 795004, Manipur
Nil
Imphal West
MANIPUR
795004
India |
| Phone |
9862824562 |
| Fax |
|
| Email |
gojendrar68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Institute of Medical Sciences, Imphal 795004, Manipur |
|
|
Primary Sponsor
|
| Name |
Shammy N |
| Address |
Post Graduate Trainee,
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Imphal 795004, Manipur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shammy N |
Regional Institute of Medical Sciences, Imphal, Manipur |
Department of Anaesthesiology,
Regional Institute of Medical Sciences, Imphal 795004, Manipur
Imphal West
MANIPUR |
9895043204
shammynazar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous Dexmedetomidine |
0.5microg/kg of Dexmedetomidine IV over 5 minutes, given 2 minutes before induction with 0.3mg/kg of Etomidate |
| Comparator Agent |
Intravenous Lignocaine |
1mg/kg of Lignocaine IV over 5 minutes, given 2 minutes before induction with 0.3mg/kg of Etomidate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II
Patients willing to participate |
|
| ExclusionCriteria |
| Details |
1. Bradycardia
2. Upper respiratory tract infection 2 weeks before surgery
3. History of allergy to study drugs (Dexmedetomidine, Lignocaine, Etomidate)
4. Diabetes Mellitus, Hypertension, Cardiovascular, Respiratory and Neurologic disease
5. Adrenocortical dysfunction
6. Morbid obesity
7. Emergency surgery patients
8. Received sedatives, analgesics or opioids within 24 hours prior to surgery
9. Communication problems |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of Myoclonus |
90 seconds |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
08/07/2021 |
| 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="0"
Months="8"
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
|
This is a randomized trial, to compare the efficacy of 0.5microg/kg of IV Dexmedetomidine and 1mg/kg of IV Lignocaine, in preventing Etomidate-induced Myoclonus, which will be conducted in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, in 104 patients in 18-65 age group, with ASA grade I and II. The study drug will be given over 5 minutes and 2 minutes after that the patient will be induced with 0.3mg/kg of Etomidate over 30 seconds. The primary outcome studied will be the incidence of myoclonus for the next 90 seconds. |