| CTRI Number |
CTRI/2025/11/096784 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
comparision of inj Propofol and inj Sodium Thiopentone as an induction agents in modified ECT |
|
Scientific Title of Study
|
A comparative study of Propofol and Sodium Thiopentone as an induction agents in Modified Electro Convulsive 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 Riddhiben Dahyabhai Patel |
| Designation |
First year resident |
| Affiliation |
Gujrat Adani Institute Of Medical Science , G .K . General Hospital , Bhuj. |
| Address |
Department of Anaesthesiology , Gujarat Adani Institute of Medical Science Bhuj , G. K. General Hospital Bhuj.
Kachchh
GUJARAT
370001
India |
| Phone |
9687590273 |
| Fax |
|
| Email |
patelriddhi.968@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Jaldeep Patel |
| Designation |
Professor , Department of Anaesthesiology |
| Affiliation |
Gujrat Adani Institute Of Medical Science , G .K . General Hospital , Bhuj. |
| Address |
Department of Anaesthesiology , 2nd Floor , Gujarat Adani Institute Of Medical Science Bhuj , G. K. Genaral Hospital , Bhuj.
Kachchh
GUJARAT
370001
India |
| Phone |
9537139646 |
| Fax |
|
| Email |
jaldeep.patel@gaims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Riddhiben Dahyabhai Patel |
| Designation |
First year resident |
| Affiliation |
Gujrat Adani Institute Of Medical Science , G .K . General Hospital , Bhuj. |
| Address |
Department Of Anaesthesiology , Gujarat Adani Institute of Medical Sciences , G. K. General Hospital, Bhuj
Kachchh
GUJARAT
370001
India |
| Phone |
9687590273 |
| Fax |
|
| Email |
patelriddhi.968@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded plus drugs procured from institute pharmacy G K General Hospital attached to Gujarat Adani Institute Of Medical Sciences , Bhuj , Kachchh , 370001 , INDIA |
|
|
Primary Sponsor
|
| Name |
Dr Riddhiben Patel |
| Address |
Department of Anaesthesiology , 2nd Floor , Gujarat Adani Institute of Medical Sciences, G.K. General Hospital Bhuj |
| Type of Sponsor |
Other [Self sponsored ] |
|
|
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 Riddhiben Dahyabhai Patel |
G.K.General Hospital Bhuj |
Department of Anaesthesiology Gujarat Adani Institute Of Medical Sciences Bhuj
Kachchh
GUJARAT |
9687590273
patelriddhi.968@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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Sodium Thiopentone. |
Inj Sodium Thiopentone 2.5 mg/kg i.v. given As an induction agent before Electrical stimulus. |
| Intervention |
Inj. Propofol |
Inj propofol 1 mg/kg given i.v. As an induction agent before Electrical stimulus |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2.
Patients indicated for modified ECT.
Provided informed written consent. |
|
| ExclusionCriteria |
| Details |
Allergy to any known drugs.
Pregnant orr lactating women.
Substance abuse history. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Seizure. |
After electical stimulus From first visible seizure movement to the cessation of tonic clonic activity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
12/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Modified Electroconvulsive Therapy (ECT) is widely used to treat severe psychiatric disorders like major depression, bipolar disorder, and schizophrenia. Anesthesia is essential during ECT to ensure patient comfort and safety. Among the anesthetic agents commonly used, Propofol and Thiopentone Sodium are popular due to their rapid onset and short duration of action, though they differ in clinical effects. Propofol is known for faster recovery, antiemetic effects, and minimal ECT confusion. However, it often leads to shorter seizure durations, which may affect therapeutic efficacy. On the other hand, Thiopentone provides longer seizure durations but may result in delayed recovery and greater hemodynamic fluctuations. Given these contrasting profiles, selecting the appropriate induction agent becomes crucial for optimizing ECT outcomes. This study aims to compare Propofol and Thiopentone Sodium with respect to seizure duration, hemodynamic stability, recovery time, and adverse effects in patients undergoing modified ECT. By conducting a cross-sectional study, the project seeks to provide evidence-based guidance on which agent offers a better balance between safety, efficacy, and recovery in the ECT setting. The results are expected to aid anesthesiologists in selecting the most suitable induction agent tailored to individual patient needs.
|