| CTRI Number |
CTRI/2024/03/063890 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the efficacy and safety of two anesthetic drugs etomidate and thiopentone used for electroconvulsive therapy under general anesthesia. |
|
Scientific Title of Study
|
A comparative study of etomidate versus thiopentone for modified 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 |
Rishanabh Pal |
| Designation |
DrNB Trainee Neuroanesthesia |
| Affiliation |
Institute of Neurosciences, Kolkata |
| Address |
2nd
floor. Department of Neuroanesthesia and Critical Care. Institute of
Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal.
Kolkata
WEST BENGAL
700017
India |
| Phone |
|
| Fax |
|
| Email |
rishanabh2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bibhukalyani Das |
| Designation |
Head of the Department of Neuroanesthesia and Critical Care |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute
of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal
Kolkata
WEST BENGAL
700017
India |
| Phone |
9836000519 |
| Fax |
|
| Email |
bibhukalyanidas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bibhukalyani Das |
| Designation |
Head of the Department of Neuroanesthesia and Critical Care |
| Affiliation |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute
of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal
Kolkata
WEST BENGAL
700017
India |
| Phone |
9836000519 |
| Fax |
|
| Email |
bibhukalyanidas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Neurosciences Kolkata. 185/1 A J C Bose Road, Kolkata. West Bengal. 700017 |
|
|
Primary Sponsor
|
| Name |
Institute of Neurosciences Kolkata |
| Address |
2nd floor. Department of Neuroanesthesia and Critical Care. Institute
of Neurosciences Kolkata. 185/1 A J C Bose Road. West Bengal
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Rishanabh Pal |
Institute of Neurosciences Kolkata |
2nd floor. Department
of Neuroanesthesia and
Critical Care. Institute of
Neurosciences Kolkata.
185/1 A J C Bose
Road.
Kolkata
WEST BENGAL |
9831376467
rishanabh2014@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC INSTITUTE OF NEUROSCIENCES KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, (2) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, (3) ICD-10 Condition: F315||Bipolar disorder, current episodedepressed, severe, with psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate |
Patients will receive intravenous etomidate(aqueous) 0.3 mg/Kg for General Anesthesia.
Total procedure duration 30 mins. |
| Comparator Agent |
Thiopentone |
Patients will receive intravenous thiopentone (2.5%) 5 mg/Kg for general anesthesia.
Total procedure duration 30 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
i) Patients between 18 to 65 years of age posted for modified electroconvulsive therapy.
ii) ASA1,2.
iii) Either sex
|
|
| ExclusionCriteria |
| Details |
i)Patients with a history of adverse reactions to either thiopentone or etomidate,
ii) Patients with a history of cardiovascular, respiratory, neurological disease or electrolyte imbalance
iii)Severe arterial hypertension
iv)ASA 3,4.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of seizure activity |
Onset of visible contractions to end of visible contractions |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cardiovascular and respiratory parameters (heart rate, blood pressure, oxygen saturation)
|
Basal, After induction and 1 min, 2 min, 3 min, 5 min, 10 min, 20 min, and 30 min following MECT |
| Time to recovery of consciousness and orientation |
N/A |
| Adverse effects such as nausea, vomiting, headache, and myoclonus |
Anytime in the first 12 hours after ECT. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
20/03/2024 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Anesthesia during modified electroconvulsive therapy(MECT) is a complex procedure due to the goal of exciting the brain into a seizure immediately after sedation has been induced. The practice varies in centers worldwide and the optimal method for MECT related anesthesia still remains unclear. Thiopentone and Etomidate are two commonly used agents for MECT. Thiopentone a short acting barbiturate has been a longstanding choice for MECT due to it’s rapid onset and short duration of action, however it may cause dose dependent decrease in systemic vascular resistance, stroke volume and cardiac output leading to compensatory tachycardia making it unsuitable for patients with hemodynamic instability. Etomidate a non-barbiturate hypnotic has emerged as a potential alternative to thiopentone. It exhibits rapid onset , short duration of action and hemodynamic stability during the procedure. Etomidate possesses a favorable side effect profile making it suitable for patients with comorbidities or sensitivity to certain drugs. Thiopentone and Etomidate are commonly used anesthetics for MECT, however there is a lack of consensus on which anesthetic is most appropriate for the procedure in terms of safety, efficacy and patient outcomes. Therefore the aim of the study is to compare the efficacy and safety of Thiopentone and Etomidate for MECT. |