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CTRI Number  CTRI/2024/06/068273 [Registered on: 03/06/2024] Trial Registered Prospectively
Last Modified On: 17/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Crossover Trial 
Public Title of Study   A clinical trial to compare the effects of two different drugs, in patients suffering from various mental disorders and undergoing ECT for the same. 
Scientific Title of Study   Efficacy of etomidate versus propofol on seizure duration and hemodynamics in patients undergoing modified ECT- a randomised cross over study  
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 Sumita Bhargava 
Designation  Associate professor  
Affiliation  NKP SALVE and institute of medical sciences  
Address  Department of Anaesthesiology, fourth floor, NKP Salve institute of medical sciences and research centre and LMH hospital, Digdoh hills, Hingna road, Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  7219105329  
Fax    
Email  bhargavasumita@yahoo.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sumita Bhargava 
Designation  Associate professor  
Affiliation  NKP Salve institute of medical sciences  
Address  Department of Anaesthesiology, fourth floor, NKP Salve institute of medical sciences and research centre and LMH hospital, Digdoh hills, Hingna road, Nagpur


MAHARASHTRA
440019
India 
Phone  7219105329  
Fax    
Email  bhargavasumita@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Devi Kulkarni 
Designation  Junior resident 
Affiliation  NKP SALVE institute of medical sciences  
Address  Room BF02-05, Vindhyachal hostel, NKP Salve institute of medical sciences and research centre and LMH hospital, Digdoh hills, Hingna road, Nagpur

Kolhapur
MAHARASHTRA
416008
India 
Phone  9686255942  
Fax    
Email  devisankul10@yahoo.in  
 
Source of Monetary or Material Support  
NKP SALVE institute of medical sciences and Lata Mangeshkar hospital, Digdoh hills, Hingna road, Nagpur 
 
Primary Sponsor  
Name  NKP Salve institute of medical sciences and research centre and LMH hospital Nagpur 
Address  Digdoh hills, Hingna road, Nagpur, Maharashtra,India 440019 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Devi Kulkarni  Lata Mangeshkar hospital Nagpur  Department of Anaesthesiology, NKP Salve institute of medical sciences and research centre Digdoh hills, Hingna road, Nagpur
Nagpur
MAHARASHTRA 		 9686255942

devisankul10@yahoo.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NKP SALVE institute of medical sciences and RC nd Lata Mangeshkar Hospital , Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F319||Bipolar disorder, unspecified, (2) ICD-10 Condition: F28||Other psychotic disorder not due to a substance or known physiological condition, (3) ICD-10 Condition: F259||Schizoaffective disorder, unspecified, (4) ICD-10 Condition: F209||Schizophrenia, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravenous inj etomidate to be given as induction agent.  Intravenous inj etomidate 0.2 mg/kg to be given as a single dose of induction, before applying electrical stimulus in patients undergoing modified electroconvulsive therapy. 
Comparator Agent  Intravenous inj propofol to be given as induction agent before applying electrical stimulus.  Intravenous inj propofol 1mg/kg to be given as an induction agent as a single dose,before applying electrical stimulus in patients undergoing modified electroconvulsive therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  This study will be conducted on patients suffering from a mental disorder as per ICD 11 and requiring modified electroconvulsive therapy as per the decision of the consultant psychiatrist. 
 
ExclusionCriteria 
Details  This study will be conducted on the following patients:
patients with a history of relevant drug allergy.
patients who have had prior treatment with ECT.
patients with a history of substance abuse with relevant drugs.
patients with anticipated difficult airway. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the seizure duration produced with etomidate to that with propofol in patients undergoing modified ECT.
 		 From the time application of stimulus until the subsidence of convulsions, the normal range of convulsions induced being 15-100 seconds 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the effect on haemodynamics produced with Etomidate to that with Propofol in patients undergoing modified ECT, in terms of -
1.Heart rate ,
2.Systolic blood pressure (SBP),
3.Diastolic blood pressure (DBP) ,
4.Mean arterial pressure (MAP)
5.Oxygen saturation (spo2) and
6. EtCO2
 		 1.Heart rate
2.Systolic blood pressure
3.Diastolic blood pressure
4.Mean arterial pressure
5.Oxygen saturation (spo2)

6. EtCO2
will be recorded before induction (T0), after administration of study drug(T1), during the seizure activity(T2) & after 1(T3), 3(T4), 5(T5), & 10 min (T6) of seizure activity.  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3/ Phase 4 
Date of First Enrollment (India)   14/06/2024 
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="2"
Months="11"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  nil

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a randomised, double blind cross over study to compare the effectiveness of two different drugs - etomidate 0.2 mg/kg and propofol 1mg/kg - in terms of seizure duration and hemodynamics in patients undergoing modified electroconvulsive therapy. Either of the drug  depending on the study group, will be use as an anaesthetic agent of induction before the application of electrical stimulus in a total of 80 patients, divided into groups of 40 each and suffering from a range of mental disorders according to ICD 11. This study will be conducted in the department of Anaesthesia at a tertiary care centre in Nagpur. 
The primary outcome measure will be the seizure duration measured by a stopwatch and hemodynamic changes - heart rate, systolic and diastolic blood pressure, mean arterial pressure, oxygen saturation and end tidal carbon dioxide levels by a multipurpose monitor
The secondary outcome will be measured in terms of the side effects produced by either of the drugs- pain on injection measured by the VAS scale, nausea, vomiting, postictal agitation , memory deficits measured by the MOCA and MMSE scales . 
 
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