| CTRI Number |
CTRI/2026/02/104151 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison between Propofol and Etomidate affect on haemodynamic changes, seizure duration and recovery time In modified ect. |
|
Scientific Title of Study
|
EFFECT OF PROPOFOL VERSUS ETOMIDATE ON SEIZURE DURATION, HEMODYNAMIC CHANGES AND RECOVERY TIME IN MODIFIED ECT. |
| 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 Nishtha Goel |
| Designation |
PG Resident Anesthesia Second Year |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur,
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
7988078407 |
| Fax |
|
| Email |
nishthagoel7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash Audichya |
| Designation |
Professor and Head of department Anaesthesia |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur.
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur.
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
prakash.audichya10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishtha Goel |
| Designation |
PG Resident Anesthesia Second Year |
| Affiliation |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur,
Pacific Medical College and Hospital, Bhilon ka Bedla,
Udaipur,
Udaipur
RAJASTHAN
313001
India |
| Phone |
9929721889 |
| Fax |
|
| Email |
nishthagoel7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anesthesiology and critical care, 3rd floor, Pacific Medical College and
Hospital, Udaipur, Rajesthan- 313001 |
|
|
Primary Sponsor
|
| Name |
Pacific Medical College and Hospital |
| Address |
Pacific Medical College and Hospital, Bhilon ka Bedla, N.H. 27,
Pratap Pura, Girwa, Udaipur, Rajasthan 313001 |
| Type of Sponsor |
Private 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 |
| Dr Nishtha Goel |
Pacific Medical College And Hospital |
Pacific Medical College
and Hospital, Department
of anesthesiology and
critical care,3rd floor,
Bhilon ka Bedla, Udaipur,
Rajasthan 313001
Udaipur
RAJASTHAN
Udaipur
RAJASTHAN |
7988078407
nishthagoel7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Pacific Medical College and Hospital |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ETOMIDATE |
Injection Etomidate I/v 0.2 mg/kg over 120 seconds |
| Intervention |
PROPOFOL |
Injection Propofol i/v 2mg/kg over120 seconds |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients relative given consent
2 ASA GRADE I AND II
3 Age range Adults aged 18 years to 50 years
4 ECT Indication Patients diagnosed with psychiatric conditions for which ECT is indicated |
|
| ExclusionCriteria |
| Details |
1 Patients relative refusal
2 ASA Grade more than 2
3 Known Allergy Patients with a known allergy or adverse reaction to study drug
4 Severe Cardiovascular Disorders Individuals with severe uncontrolled cardiovascular conditions e.g unstable angina recent myocardial infarction
5 Pregnancy and Lactation Pregnant or Lactating women
6 Epilepsy
7 Neuromuscular disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| For better knowledge of how patients respond to propofol and etomidate before, during and after Electro Convulsive Therapy (ECT) in order to better comprehend the anesthetic impact. |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To report any adverse effects |
24 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/03/2026 |
| 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="2"
Months="0"
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
|
This study is to compare the effect between Propofol and Etomidate on seizure duration, Hemodynamic changes and the recovery time in modified Electro Convulsion Therapy.
It is prospective double blinded study |