| 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
|
|
|
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
|
|
|
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.
|