| CTRI Number |
CTRI/2019/05/018890 [Registered on: 01/05/2019] Trial Registered Prospectively |
| Last Modified On: |
30/04/2019 |
| 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
|
Comparison between two anaesthetic drugs Propofol and Ketamine during anaesthesia in Electro Convulsive Therapy in treatment of depressive disorders. |
|
Scientific Title of Study
|
Comparative Effects of Propofol and Ketamine For modified ECT; a prospective randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Debarshi Guha |
| Designation |
Resident Anaesthesiology |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept. of Anaesthesiology
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8879526556 |
| Fax |
|
| Email |
drdebarshi.guha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Maj Gen Navdeep Sethi |
| Designation |
Commandant, Command Hospital Southern Command |
| Affiliation |
Armed Forces Medical College |
| Address |
Commandant Office
Administrative Block
Command Hospital Southern Command
Pune
MAHARASHTRA
411040
India |
| Phone |
8879526556 |
| Fax |
|
| Email |
drnsethi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Debarshi Guha |
| Designation |
Resident Anaesthesiology |
| Affiliation |
Armed Forces Medical College |
| Address |
Dept. of Anaesthesiology
Armed Forces Medical College
Pune
Pune
MAHARASHTRA
411040
India |
| Phone |
8879526556 |
| Fax |
|
| Email |
drdebarshi.guha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Command Hospital Southern Command, Pune |
|
|
Primary Sponsor
|
| Name |
Armed Forces Medical College |
| Address |
Solapur Road, Wanowrie, Pune
PIN 411040 |
| 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 |
| Dr Debarshi Guha |
Armed Force Medical College |
Thirumalai Hall, Dept of Anaesthesiology and Critical Care, Academic Building
Pune
MAHARASHTRA |
8879526556
drdebarshi.guha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Research Cell & Institutional Ethical committee, AFMC Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F333||Major depressive disorder, recurrent, severe with psychotic symptoms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj Ketamine |
induction by Inj Ketamine 0.8-1.2 mg/Kg in modified ECT |
| Intervention |
Inj Propofol |
induction by Inj Propofol 1.5mg/ Kg in modified ECT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All patients of age more than 18 yrs scheduled for ECT |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent
2. Raised intracranial pressure
3. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparison of Duration of seizure (both motor and EEG) between Propofol and Ketamine when used in modified ECT |
outcome will be assessed immediately after administering the drug till the time the seizure will last. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
15/05/2019 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a prospective, single blind, randomized control trial comparing the effects of Propofol and Ketamine in modified ECT which will be conducted in a tertiary care hospital in India. The ECT sessions will be randomized in two groups of 22 each. The first group will be given Propofol as the induction agent and the second group will be given Ketamine as the induction agent. As per their randomization each patient will be given inj Propofol 1.5 mg/kg iv or inj Ketamine 0.8-1.2 mg/kg iv. The primary objective will be comparison of duration of seizure (both motor and EEG) between Propofol and Ketamine. |