| CTRI Number |
CTRI/2023/09/057361 [Registered on: 11/09/2023] Trial Registered Prospectively |
| Last Modified On: |
09/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to compare the effectiveness of KETOFOL AND KETOFOL-DEXMEDETOMIDINE drugs in patients undergoing modified electroconvulsive therapy. |
|
Scientific Title of Study
|
A randomised clinical trial to compare the effectiveness of KETOFOL and KETOFOL-DEXMEDETOMIDINE groups 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 |
Charishma Buddha |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College ,Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College,Bangaramma Sajjan Campus,Vijayapura Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8919259121 |
| Fax |
|
| Email |
charishma.goutham@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
D G Talikoti |
| Designation |
Professor |
| Affiliation |
Shri B M Patil Medical College, Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College,Bangaramma Sajjan Campus,Vijayapura Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
9844260391 |
| Fax |
|
| Email |
dtalikoti@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Charishma Buddha |
| Designation |
Junior Resident in Anaesthesiology |
| Affiliation |
Shri B M Patil Medical College ,Vijayapura |
| Address |
Department of Anaesthesiology,Shri B M Patil Medical College,Bangaramma Sajjan Campus,Vijayapura Bijapur
Bijapur
KARNATAKA
586103
India |
| Phone |
8919259121 |
| Fax |
|
| Email |
charishma.goutham@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri B M Patil Medical College,Bangaramma Sajjan Campus,BLDE University,Vijayapura,Karnataka,Pin 586103 |
|
|
Primary Sponsor
|
| Name |
Shri B M Patil Medical College |
| Address |
Bangaramma Sajjan Campus,BLDE University,Vijayapura,Karnataka,Pin 586103
|
| 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 |
| Charishma Buddha |
Shri B M Patil Medical College |
Department of Anaesthesiology, Bangaramma Sajjan Campus,BLDE University,Vijayapura,
Bijapur
KARNATAKA |
8919259121
charishma.goutham@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri B M Patil Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, (2) ICD-10 Condition: F01-F99||Mental, Behavioral and Neurodevelopmental disorders, (3) ICD-10 Condition: F20-F29||Schizophrenia, schizotypal, delusional, and other non-mood psychotic disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ketofol |
K.F. group 10 ml of 0.9% saline was infused intravenously over a period of 10 minutes and 10 minutes before the procedure.
|
| Intervention |
ketofol-dexmedetomidine |
In KFD -group 0.5 μg/kg dexmedetomidine (diluted to 10 ml with 0.9% saline) was infused intravenously over a period of 10 minutes and 10 minutes prior to the procedure.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA Grade I & II |
|
| ExclusionCriteria |
| Details |
Cardiovascular disease,
Cerebrovascular disorder,
Intracranial hypertension,
Respiratory tract disease,
Glaucoma,
Presence of a pacemaker,
History of seizures,
ASA III –V physical status,
History of allergy to the study drugs,
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess seizure duration
To evaluate an acceptable decrease in heart rate & blood pressure (systolic, diastolic)
|
5 & 10 & 30 minutes after the end of the seizure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess agitation
|
24 hours |
| To assess depression , mania, psychosis |
24 hours |
To assess early post-M.E.C.T. complications.
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1 |
|
Date of First Enrollment (India)
|
19/09/2023 |
| 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="30" |
|
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
|
A Randomised clinical trial to compare the effectiveness of ketofol and ketofol-dexmedetomidine group in patients undergoing modified electroconvulsive therapy. Patients will be divided randomly into two equal groups, consisting of thirty patients each, the ketofol (K.F. group and ketofol-dexmedetomidine( KFD) group).This study will be carried out in the Department of Anaesthesiology, B.L.D.E.U.’s Shri. B.M. Patil Medical College, Hospital and Research Centre, Vijayapura . The primary outcome is to assess seizure duration and to evaluate an acceptable decrease in heart rate and blood pressure (systolic, diastolic) .The secondary outcome is to assess agitation ,to assess depression , mania, psychosis and to assess early post-M.E.C.T. complications. |