| CTRI Number |
CTRI/2024/03/064547 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying effect of propofol and ketamine as induction agents in electro convulsive therapy in patients with depression. |
|
Scientific Title of Study
|
A comparative study of effectiveness of propofol and ketamine as induction agent for electro convulsive therapy in patient with severe depression. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapuri Manasa |
| Designation |
Junior Resident(JR); Department of Anaesthesia |
| Affiliation |
Mahatma Gandhi Missions Medical College and Hospital |
| Address |
Dept of Anaesthesiology; 2nd floor, MGM Medical College and Hospital, N6, CIDCO, Aurangabad
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9381692170 |
| Fax |
|
| Email |
kapurimanasa.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sasturkar Vasanti Mukund |
| Designation |
MBBS,MD, Professor (dept. of anaesthesia, MGM Medical College and Hospital) |
| Affiliation |
MGM Medical College and Hospital |
| Address |
MGM Medical College and Hospital, N6, CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantims@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sasturkar Vasanti Mukund |
| Designation |
MBBS,MD, Professor (dept. of anaesthesia, MGM Medical College and Hospital) |
| Affiliation |
MGM Medical College and Hospital |
| Address |
MGM Medical College and Hospital, N6, CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9370668196 |
| Fax |
|
| Email |
vasantims@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital; N6, CIDCO; Aurangabad. |
|
|
Primary Sponsor
|
| Name |
Kapuri Manasa |
| Address |
MGM Medical College and Hospital, N6, CIDCO, Aurangabd. |
| Type of Sponsor |
Other [self] |
|
|
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 Kapuri Manasa |
MGM Medical College and Hospital |
Department of Anaesthesiology; 2nd floor
N6, CIDCO, Aurangabad.
Aurangabad
MAHARASHTRA |
9381692170
kapurimanasa.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Mahatma Gandhi Missions Ethics Committee for Research on Human Subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F332||Major depressive disorder, recurrent severe without psychotic features, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ketamine |
Effectiveness of ketamine as induction agent in electro convulsive therapy in patients with severe depression
duration of data collection -till 6 weeks after ect |
| Comparator Agent |
Propofol |
Effectiveness of propofol as induction agent in ectro convulsive therapy in patients with severe depression
duration of data collection-till 6 weeks after ect |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes between age 18-65 years.
Patients with severe depressive disorder requiring electro convulsive therapy.
Patients with American Society of Anaesthesiology (ASA) physical status l & ll . |
|
| ExclusionCriteria |
| Details |
Pregnant females and lactating mothers.
Patients on chronic opiate use such as tramadol.
Known allergies to study drugs.
Patients with hypertension, IHD and other heart diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A)
1)Mean blood pressure
2)Heart rate
3)Oxygen Saturation
B)
1)Spontaneous eye opening
2)Obeying verbal commands
C)
MADRS(Montgomery Asberg Depression Rating Scale) |
A)
2min before premedication
2min after induction
5min, 10min, 15min, 20min after giving shock and onset of seizures
B)
0min, 5min,10min, 15min post ect
C)
1st & 2nd week post ect |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Seizure duration |
10 min after induction |
| Incidence & severity of post ect agitation |
15 min post ect |
| Incidence & severity of post ect myalgia |
6hrs & 12hrs post ect |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| 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="2"
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
|
This clinical trail is a comparative study of propofol and ketamine as induction agents for electro convulsive therapy in patients with severe depression. This is a double blinded study. |