| CTRI Number |
CTRI/2023/01/049228 [Registered on: 25/01/2023] Trial Registered Prospectively |
| Last Modified On: |
24/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to Compare Different Anesthetic agents as a cause of Delirium after ECT |
|
Scientific Title of Study
|
Post Electroconvulsive Therapy Delirium and Anesthesia: A Randomised Clinical Study Comparing Thiopental, Propofol and Etomidate. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sonali Dagar |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
Government Medical College, Kota |
| Address |
Department of Psychiatry, New Medical College and Hospital, Rangbari, Kota
Kota
RAJASTHAN
324005
India |
| Phone |
9660890059 |
| Fax |
|
| Email |
sonali.dagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Daria |
| Designation |
Professor |
| Affiliation |
Government Medical College Kota |
| Address |
Department of Psychiatry, New Medical College and Hospital, Rangbari, Kota
Kota
RAJASTHAN
324005
India |
| Phone |
9461182794 |
| Fax |
|
| Email |
drvinodusha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Kumar Daria |
| Designation |
Professor |
| Affiliation |
Government Medical College Kota |
| Address |
Department of Psychiatry, New Medical College and Hospital, Rangbari, Kota
RAJASTHAN
324005
India |
| Phone |
9461182794 |
| Fax |
|
| Email |
drvinodusha@gmail.com |
|
|
Source of Monetary or Material Support
|
| New Medical College Hospital, Government Medical College, Kota |
|
|
Primary Sponsor
|
| Name |
Government Medical College Kota |
| Address |
Rangbari Road, Sector A, Rangbari , Kota, Rajasthan |
| Type of Sponsor |
Government 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 |
| Sonali Dagar |
New Medical College Hospital, Kota |
Room No. 206, First Floor , Department of Psychiatry
Kota
RAJASTHAN |
9660890059
sonali.dagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and A.G. Hospital, Kota |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F30-F39||Mood [affective] disorders, (2) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Etomidate |
Etomidate according to body weight to achieve anesthesia for Electroconvulsive Therapy. |
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Propofol |
Propofol according to body weight to achieve anesthesia for Electroconvulsive Therapy. |
| Intervention |
Thiopental |
Thiopental according to body weight to achieve anesthesia for Electroconvulsive Therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients above 18 years of age.
2. Patients whose informed consent has been obtained.
3. Only the first session of ECT during current admission of the patient will be studied.
|
|
| ExclusionCriteria |
| Details |
1. Patient who have received ECT during the last one year.
2. Patients with clinically significant laboratory abnormality or ECG findings.
3. Patients with delirium.
4. Patients with organic or neurological disease.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The role of thiopental, propofol, etomidate on Post- ECT delirium and recovery. |
Patient alertness will be assessed using Richmond Agitation- Sedation Scale and delirium with Confusion Assessment Method for the ICU at 15 min, 30 min and 1 hour after eye opening. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify predictors of Post ECT delirium and recovery.
|
Predictors of Post Electroconvulsive therapy delirium |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2023 |
| Date of Study Completion (India) |
30/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Various number of anesthetic agents are being used today but a very limited number of studies are based on comparing influence of different agents simultaneously on post ECT delirium. Keeping in view the above facts, we have taken up this study with the objective to examine the role of different anesthetic agents on post- ECT delirium and to identify variables responsible for delirium after ECT. Each patient will undergo comprehensive evaluation .IQCODE will be used to assess the premorbid cognitive functioning.All patients to be oxygenated before ECT with 100% oxygen by mask. Continuous hemodynamic monitoring will be done. General anesthesia and paralysis will be induced by anesthetic agent and succinylcholine, respectively to achieve adequate depth of anesthesia. Brief Pulse ECT with bitemporal electrode placement using half age method will be administered to the patient using RMS PC ECTON machine (indigenous machine). Electrical parameters will be recorded.. Patient alertness will be assessed using Richmond Agitation- Sedation Scale and delirium with Confusion Assessment Method for the ICU at 15 min, 30 min and 1 hour after eye opening. |