| CTRI Number |
CTRI/2025/03/082682 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
18/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Benefit of drugs in post convulsion distress after Electro convulsive therapy |
|
Scientific Title of Study
|
Effectiveness of Pretreatment Administration of Dexmedetomidine and Fentanyl for Post ICTAL Agitation after 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 Keerthi P |
| Designation |
post graduate resident,anaesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
OT,2nd floor,Department of Anaesthesiology,Block 1,GMC,Bhopal
MP-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9500248492 |
| Fax |
|
| Email |
keerthikerub96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Dhawale |
| Designation |
Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
OT,2nd floor,Department of Anaesthesiology,Block 1,GMC,Bhopal
MP-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425667373 |
| Fax |
|
| Email |
yashwantdhawalegmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sweyta Shrivastava |
| Designation |
Assistant Professor in Department of Anaesthesiology |
| Affiliation |
Gandhi Medical College |
| Address |
OT,2nd floor,Department of Anaesthesiology,Block 1,GMC,Bhopal
MP-462001
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9425543210 |
| Fax |
|
| Email |
sweyta2907@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gandhi Medical College Block A Second Floor Operation Theatre Gandhi Medical College and Associated Hamidia Hospitals Bhopal MADHYA PRADESH India 462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Sultania Road Royal Market Bhopal MP India 462001 |
| 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 Sweyta Shrivastava |
Hamidia Hospital |
Operation Theatre No 5 Block A Second Floor Department of Anaesthesiology Gandhi Medical College Sultania Road Bhopal Madhya Pradesh India 462001
Bhopal
MADHYA PRADESH |
9425543210
sweyta2907@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE GANDHI MEDICAL COLLEGE BHOPAL MP INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G||Mental Health, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
Standard anaesthesia protocol will be followed and patients will be premedicated with IV Glycopyrrolate 0.2mg, Ondansetron 4mg and dexmedetomidine 0.5mcg/kg body weight 10 mins before induction of anaesthesia and pre-oxygenated with 100% oxygen for 3 minutes at flow rate of 6-8 L/min. A bite block was used to protect the teeth, lip and tongue. The patient will be induced with the calculated dose of propofol (1mg/kg) and succinylcholine (1mg/kg) will be given and patient will be ventilated manually till electrical stimulus applied. Hemodynamic parameters such as HR, MAP, RR and SPO2 will be recorded at the following intervals: Baseline After induction during ECT, just after ECT,5 mins,10 mins,15 mins,30 mins,45mins,60mins.Induction time, ICTAL duration, recovery time, and side effects will be observed. After achieving stable spontaneous breathing and demonstrating protective reflexes, patients were moved to post interventional recovery room, where continued monitoring of the patient will be done |
| Comparator Agent |
Fentanyl |
Standard anaesthesia protocol will be followed and patients will be premedicated with IV Glycopyrrolate 0.2mg, Ondansetron 4mg and fentanyl 1 mcg/kg body weight 10 mins before induction of anaesthesia and pre-oxygenated with 100% oxygen for 3 minutes at flow rate of 6-8 L/min. A bite block was used to protect the teeth, lip and tongue. The patient will be induced with the calculated dose of propofol (1mg/kg) and succinylcholine (1mg/kg) will be given and patient will be ventilated manually till electrical stimulus applied. Hemodynamic parameters such as HR, MAP, RR and SPO2 will be recorded at the following intervals: Baseline After induction during ECT, just after ECT,5 mins,10 mins,15 mins,30 mins,45mins,60mins.Induction time, ICTAL duration, recovery time, and side effects will be observed. After achieving stable spontaneous breathing and demonstrating protective reflexes, patients were moved to post interventional recovery room, where continued monitoring of the patient will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 & 2,pt with major psychiatric disorder |
|
| ExclusionCriteria |
| Details |
patient & attender refusal,risk of aspiration,cardivascular disease,neuromascular disease,pt with implants,pregnancy,drug allergy,active respiratory diseases |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Dexmedetomidine & Fentanyl for attenuation of post ictal agitation after ECT |
hemodynamic parameters at 5,10,15,30,45 mins after ECT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| role of Dexmedetomidine & Fentanyl in hemodynamic responses & recovery time after ECT |
at 5,10,15,30,45 mins |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
18/04/2025 |
| 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="11"
Days="30" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [keerthikerub96@gmail.com].
- For how long will this data be available start date provided 17-02-2025 and end date provided 18-02-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
ECT is a common treatment method used in severe depression and other psychiatric diseases. Most ECT procedures are carried out with muscle paralysis under general anaesthesia. Therapeutic adequacy of ECT can be determined by monitoring the seizure duration whic can be done by observation of motor seizure or EEG. The study will be conducted between 18 to 40 yrs of age. In this study, half of the patient will be given with dexmedetomidine and other half will be given with fentanyl. |