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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  
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 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  
Status 
Not Applicable 
 
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

 
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