| CTRI Number |
CTRI/2024/09/073405 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
"Comparison of two Anaesthesia Drugs Thiopental and Etomidate during Electroconvulsive Therapy. (ECT)†|
|
Scientific Title of Study
|
Comparative study between
Thiopental and Etomidate on Haemodynamic characteristics during 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 |
DR ROSAMMA K J |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Hind Institute of Medical sciences sitapur |
| Address |
HIND INSTITUTE OF MEDICAL SCIENCES
MAU ATARIA SITAPUR
ANAESTHESIOLOGY DEPARTMENT,
2ND FLOOR OPD.
SITAPUR
UTTAR PRADESH 261303
INDIA
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
7234028415 |
| Fax |
|
| Email |
daisyholycross@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ROSAMMA KJ |
| Designation |
ANESTHESIA JUNIOR RESIDENT |
| Affiliation |
ATAL BIHARI VAJPAYEE MEDICAL UNIVERSITY |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
HIND INSTITUTE OF MEDICAL SCIENCES.
MAU, ATARIA, SITAPUR
Chack Ganjaria Road
Sultanpur
Lucknow, U P 226002
Lucknow
UTTAR PRADESH
261303
India |
| Phone |
7234028415 |
| Fax |
|
| Email |
daisyholycross@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR .ROSAMMA K J |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Hind Institute of Medical sciences Sitapur |
| Address |
HIND INSTITUTE OF MEDICAL SCIENCES
MAU ATARIA SITAPUR.
Anaesthesiology Department, 2nd Floor, OPD Block, Sitapur
Sitapur
UTTAR PRADESH
261303
India |
| Phone |
7234028415 |
| Fax |
|
| Email |
daisyholycross@gmail.com |
|
|
Source of Monetary or Material Support
|
| HIND INSTITUTE OF MEDICAL SCIENCES, MAU, ATARIA, SITPAUR, UP |
|
|
Primary Sponsor
|
| Name |
HIND INSTITUTE OF MEDICAL SCIENCES SITAPUR |
| Address |
HIND INSTITUTE OF MEDICAL SCIENCES.
MAU,ATARIA,SITAPUR
Pin-261303 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr B B Yadav |
Hind medical college sitapur,mau ataria pin-261303 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR BHARAT BHUSHAN YADAV |
HIND INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY, HIND INSTITUTE OF MEDICAL SCIENCES MAU ATARIA UP 261303
Sitapur
UTTAR PRADESH |
9335902918
bharatbhushanyadavlko@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMUNICATION OF DECISION OF THE INSTITUTIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F23||Brief psychotic disorder, (2) ICD-10 Condition: F200||Paranoid schizophrenia, (3) ICD-10 Condition: F250||Schizoaffective disorder, bipolartype, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate in modified electroconvulsive Therapy |
Etomidate 0.2mg /kg[0.2%]injected intravenously and the patient is monitored for 60 minutes after the procedure |
| Intervention |
Thiopental during modified electroconvulsive therapy |
Thiopental sodium 4mg/kg [2.5%]injected intravenously monitored for 60 minutes after the procedure |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2 patients scheduled to under go ECT for various indications .
Hemodynamically stable at the time of ECT |
|
| ExclusionCriteria |
| Details |
Patients refused to participate in the study
Allergy to trial drugs
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Thiopental and Etomidate on hemodynamic changes during ECT |
18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of Thiopental and Etomidate with respect to duration of clinical seizure
To compare the recovery time between Thiopental and Etomidate
To compare adverse drug reactions between Thiopental and Etomidate
Assessment of the cognitive function before and after ECT |
18 months |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 (ECT) employs an electric current to generate a generalized cerebral seizure under controlled conditions by electrically stimulating one or both the cerebral hemispheres. The indications for the ECT use include: “severe depression, patients with schizophrenia, schizoaffective disorder, catatonia, neuroleptic malignant syndrome, and bipolar disorderâ€, etc. It was introduced in the year 1937 by Celletti and Bini. It is generally done under intravenous sedation or general anaesthesia. The primary objective of the anaesthesia during ECT is to keep the haemodynamic and related complications under control. The other associated objectives are to ensure the primary requirements of amnesia and muscle relaxation. the anaesthesia must be optimum enough to suppress the potentially dangerous cardiac and/or central nervous system responses without affecting the treatment Efficacy. AIM AND OBJECTIVES This study was undertaken to compare the effects of Intravenous [IV] Sodium ThiopentoneandEtomidate used as IV anesthetic agents in Modified ECT as regards, Haemodynamic changes, duration of clinical seizure and adverse drug reactions between Thiopental and Etomidate. MATERIALS AND METHODS A total of 110 patients in the age group of 18-60 of either sex, ASA I/II Patients scheduled to undergo ECT for various indications and haemodynamically stable at the time of ECT were divided randomly into two equal groups. Group E (n=55) –received 0.2 mg/kg Etomidate (0.2%) injected intravenously over 30 to 60 seconds. Group T (n=55) received 4 mg/kg (2.5%) Thiopental sodium injected intravenously over 30 to 60 seconds.All the patients were monitored for changes HR, SBP, DBP, MAP and SpO2 at baseline and after induction every minute for 15min and after that every 2 min till recovery of ECT. Duration of recovery was recorded from injection of anaesthetic agent to time taken to obey vocal commands such as opening of eyes, tongue protrusion, head lift, finger grasping. Adverse drug reactions, if any were also be noted. In post procedure room, patient was followed for next 60 minutes. CONCLUSION: We found that Etomidate offers superior hemodynamic stability during induction compared to Thiopentone. Etomidate had definite advantage of longer seizure duration compared to Thiopentone.However, it was associated with myoclonic jerks during induction.
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