| CTRI Number |
CTRI/2023/08/056304 [Registered on: 09/08/2023] Trial Registered Prospectively |
| Last Modified On: |
08/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of 2 medicines in electric shock therapy |
|
Scientific Title of Study
|
Clinical efficacy of Propofol and Etomidate in Electroconvulsive therapy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ayushi Chhatrashali |
| Designation |
Junior Resident in Department of Anaesthesiology |
| Affiliation |
Gandhi medical college |
| Address |
Operation theatre, 2nd floor, Department of Anaethesiology, Hamidia hospital, Gandhi medical college, bhopal, mp Gandhi medical college Bhopal MADHYA PRADESH 462001 India |
| Phone |
8319639265 |
| Fax |
|
| Email |
ayushichhatrashali4559@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yashwant Dhawale |
| Designation |
Professor in Department of Anaethesiology |
| Affiliation |
Gandhi medical college |
| Address |
Operation theatre, 2nd floor, Department of Anaethesiology, Hamidia hospital, Gandhi medical college, bhopal, mp Gandhi medical college Bhopal MADHYA PRADESH 462001 India |
| Phone |
9425667373 |
| Fax |
|
| Email |
yashwantdhawalegmc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajkumar Ahirwal |
| Designation |
Associate professor in Department of Anaethesiology |
| Affiliation |
Gandhi medical college |
| Address |
Operation theatre, 2nd floor, Department of Anaethesiology, Hamidia hospital, Gandhi medical college, bhopal, mp Gandhi medical college Bhopal MADHYA PRADESH 462001 India |
| Phone |
9826742427 |
| Fax |
|
| Email |
drrajkumarahirwal@ymail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gandhi medical college, Bhopal |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Ayushi Chhatrashali |
Gandhi medical college, Bhopal |
Department of Anaesthesiology, Block 1, Room no. 1, Hamidia Hospital Bhopal MADHYA PRADESH |
8319639265
ayushichhatrashali4559@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group 18-60 years
2. Patients of both SEX
3. ASA Grade 1&2
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Patients aged below 18 and above 60 years
Patients with risk of aspiration
Cardiovascular disease
Neuromuscular problems
Major sicknesses like Bronchial asthma and Tuberculosis
Patients with implants
Pregnancy
Drug allergy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effects of propofol & etomidate in attenuation of the stress response, induction time, seizure duration, & recovery time during ECT. |
Immediately after induction till 10 min after procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe the occurance of any side effects & complications of ECT.
To observe the occurrence of any side effects and complications related to propofol and etomidate.
|
Immediately after induction till 10 min after procedure |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
18/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
18/08/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="4" Days="1" |
|
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
|
| · Electroconvulsive therapy also known as ECT is used in the treatment of severe psychiatric disorders such as bipolar mood disorders, schizophrenia, catatonic psychosis, and delirium and non-responders of pharmacological therapy. · It involves induction of a seizure as a therapeutic method by the administration of a variable frequency electric stimulus, applied through electrodes to the scalp. · ECT can produce severe disturbance in the cardiovascular system and a marked increase in cerebral blood flow and intracranial pressure. These changes may be altered using various anaesthetic drugs. · Certain anaesthetic agents on account of their anticonvulsant properties have a negative impact on motor seizure duration. Etomidate and Propofol being devoid of the strong anticonvulsant property may be beneficial for use in ECT. · The goal of anaesthetic agents in ECT is to get an unconscious patient with muscle paralysis and amnesia and to decrease its hyperdynamic response. · Propofol is an ultra-short-acting intravenous induction agent with some favorable properties like smooth induction, quick recovery, and antiemetic properties. It is deemed not a suitable agent in patients with cardiovascular instability and shock as it decreases blood pressure, cardiac output, and systemic vascular resistance due to inhibition of sympathetic vasoconstriction and impairment of the baroreceptor reflex regulatory system · Etomidate is one of the induction agents which is claimed to be cardiostable and had gained a lot of popularity in the past and fell out of use due to adrenocortical suppression. Further studies in recent years on etomidate have yielded promising results and it has regained its popularity as a safe anaesthetic and more so in sepsis and hemodynamically unstable and critically ill patients · For ECT purpose adequate seizure duration should last around 25-30 seconds | |