| CTRI Number |
CTRI/2016/01/006530 [Registered on: 15/01/2016] Trial Registered Retrospectively |
| Last Modified On: |
19/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To evaluate the effect of two different anesthetic agents on electroconvulsive therapy for psychiatric patients |
|
Scientific Title of Study
|
Comparison of effect of etomidate with propofol on haemodynamics during modified electroconvulsive therapy . |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divya Mehta |
| Designation |
Post graduate Junior resident |
| Affiliation |
Government Medical college and Hospital , Sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care
D Block ,5th Floor
Government Medical College and Hospital
Sector 32
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9780932491 |
| Fax |
|
| Email |
dimsymehta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Palts |
| Designation |
Associate Professor |
| Affiliation |
Government Medical college and Hospital , Sector 32 , Chandigarh |
| Address |
Department of Anaesthesia and Intensive care, Level 5 ,D Block ,Government Medical College and Hospital ,Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richard saroa |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical college and Hospital , Sector 32 , Chandigarh |
| Address |
1208 ,Sector 32 B
Department of Anaesthesia and Intensive care, Level 5, D Block, Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9780932491 |
| Fax |
|
| Email |
dimsymehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Director principal ,Government Medical college and Hospital , Sector 32 ,Chandigarh |
|
|
Primary Sponsor
|
| Name |
Divya Mehta |
| Address |
DIRECTOR PRINCIPAL ,LEVEL 2 BLOCK B ,GMCH ,SECTOR 32 ,CHANDIGARH |
| Type of Sponsor |
Government 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 |
| Divya Mehta |
Government Medical College and Hospital , Chandigarh |
Department of Anaesthesia and Intensive care, Level 5, D Block, Government Medical college and Hospital ,Sector 32 Chandigarh
Chandigarh
CHANDIGARH |
9780932491
dimsymehta@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ( GMCH Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients suffering from mental disorder as per ICD 10 requiring Electroconvulsive therapy advised by Consultant Psychiatrist, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate |
Effect of etomidate( as induction agent during anaesthesia) on haemodynamics and motor seizure duration is studied during electroconvulsive therapy |
| Comparator Agent |
Propofol |
Effect of propofol( as induction agent during anaesthesia) on haemodynamics and motor seizure duration is compared with etomiadate during electroconvulsive therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from a mental disorder as per ICD 10 necessitating Electroconvulsive therapy decided by Consultant Psychiatrist.
ASA grade 1 and 2 patients
BMI > 18 and <25 kg/m2 |
|
| ExclusionCriteria |
| Details |
Patients with history of relevant drug allergy.
Patients with severe cardiovascular or neurological or respiratory disorder.
Patients with history of substance use or drug abuse. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean Blood Pressure |
Before induction , after administration of study drug , during seizure , 1 ,3,5 and 10 minutes after the seizure . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate |
Before induction , after administration of study drug , during seizure , 1 ,3,5 and 10 minutes after the seizure . |
| Systolic Blood Pressure |
Before induction , after administration of study drug , during seizure , 1 ,3,5 and 10 minutes after the seizure . |
| Diastolic Blood pressure |
Before induction , after administration of study drug , during seizure , 1 ,3,5 and 10 minutes after the seizure |
| O2 saturation(SpO2) |
Before induction , after administration of study drug , during seizure , 1 ,3,5 and 10 minutes after the seizure . |
| Motor seizure duration |
Measured by stop watch by isolated arm technique. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2014 |
| Date of Study Completion (India) |
19/08/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The main aim of this study is to find an ideal induction agent for anaesthesia during modified electroconvulsive therapy .Etomidate has been found to prevent haemodynamic changes during seizure .It also increases seizure duration .The studies revealed that more is the seizure duration , more is the therapeutic efficacy of electroconvulsive therapy.An ideal anaesthetic agent should be able to minimise haemodynamic changes without significant effect on seizure duration. This study compares the effect of etomidate with propofol on haemodynamics as well as seizure duration . |