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CTRI Number  CTRI/2024/11/077205 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 06/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two drugs Injection remifentanil and injection fentanyl on seizure duration during electroconvulsive therapy 
Scientific Title of Study   To evaluate and compare effects of remifentanil and fentanyl on seizure duration , recovery parameters and degree of stimulus amplitude in patients undergoing 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  Ajay Malik 
Designation  Resident 
Affiliation  Shri Guru Ram Rai Institute Of Medical And Health Sciences, dehradun 
Address  Department of Aaesthesia , Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun , uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  9997707555  
Fax    
Email  ajaymalik0165@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nishith Govil 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun 
Address  Department of Anaesthesia , Shri Guru Ram Rai Institute of Medical and Health SCIENCES, Dehradun , Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  8126101759  
Fax    
Email  nishithgovil@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nishith Govil 
Designation  Professor 
Affiliation  Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun 
Address  Department of Anaesthesia , Shri Guru Ram Rai Institute of Medical and Health SCIENCES, Dehradun , Uttarakhand


UTTARANCHAL
248001
India 
Phone  8126101759  
Fax    
Email  nishithgovil@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , Shri Guru Ram Rai Institute of Medical and Health Sciences , Dehradun  
 
Primary Sponsor  
Name  Dr Nishith Govil ,Professor Department of Anaesthesiology 
Address  Shri Guru Ram Rai Institute of Medical and Health Sciences, Dehradun  
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 Ajay Malik  Shri guru Ram rai medical college dehradun   Department of anaesthesia shri guru Ram rai medical college dehradun
Dehradun
UTTARANCHAL 
9997707555

ajaymalik0165@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES. PATEL NAGARDEHRADUN   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  fentanyl with propofol  patient will be given fentanyl 1 microgram/ kg along with propofol 
Comparator Agent  propofol  patient will given 0.5 mg kg-1 IV bolus propofol over 20 seconds and then 10 mg IV bolus propofol titrated over 10-second intervals to achieve loss of consciousness  
Intervention  remifentanil with propofol  patient will be given remifentanil 1 microgram/ kg along with propofol 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients suffering with major depressive disorder , psychosis or bipolar disorder.
 
 
ExclusionCriteria 
Details  Patients having heart diseases, unregulated hypertension, endocrinologic disorders and allergic to test drugs.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Duration of seizure induced  time from electrical stimulus to cessation of tonic clonic motor activity 
 
Secondary Outcome  
Outcome  TimePoints 
hemodynamic parameters, recovery profile and adverse events  induction time to comprehension time and after procedure 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/12/2024 
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="1"
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  

Modified electroconvulsive therapy (ECT) is commonly used for treatment of depression, mania and affective disorders (1). The mechanism of action is not clearly understood but seizures are necessary for a therapeutic response (2). Prolonged seizures may be more efficacious (3) and a motor seizure duration of greater than 25 s has been recommended to ensure clinical adequacy of treatment (4). Cognitive side-effects and the duration of the period of disorientation are no more prominent with increased seizure duration but rather correlate to the amount of electrical stimulation and electrode placement used during treatment (5-7).

General anesthesia is used during ECT (8). Since most short-acting anaesthetics have anticonvulsant effects, they can increase the threshold and inhibit spread of the seizure, thus modifying the seizure activity and shortening its duration (9).

Fentanyl is a rapid-acting opioid with a moderate duration of action and has no known anticonvulsant effect. Combining fentanyl with propofol produces loss of consciousness with a smaller induction dose of propofol and thus could potentially increase seizure duration (10). Fentanyl is widely used as analgesic in ECT anesthesia because of characteristics such as minimal postoperative confusion and a lower incidence of hypertension or tachycardia during induction of anesthesia. 

Remifentanil is a potent ultra short-acting opioid and has no known anticonvulsant effect. Recently, administration of remifentanil in combination with propofol was reported to increase the duration of seizure activity in patients undergoing ECT (5).

The goal of this study was to evaluate and compare effects of remifentanil and fentanyl on seizure duration, recovery parameters and degree of stimulus amplitude in patients undergoing ECT.

 

 
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