| CTRI Number |
CTRI/2025/11/096775 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
31/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Dexmedetomidine in reducing fasciculations and muscle ache caused by the drug Succinylcholine in patients undergoing electroconvulsive therapy |
|
Scientific Title of Study
|
Evaluation of effect of Dexmedetomidine on Succinylcholine induced fasciculations and myalgia in patients undergoing 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 |
Vidya V |
| Designation |
Postgraduate resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi
A5, Tower 2, Type 5, GPRA Complex, Kidwai Nagar East, South West Delhi
South West
DELHI
110029
India |
| Phone |
8754717436 |
| Fax |
|
| Email |
vidyav1010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhu Dayal |
| Designation |
Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi
Department of Anaesthesia, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi
South
DELHI
110029
India |
| Phone |
9811271996 |
| Fax |
|
| Email |
drmadhudayal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
VIDYA V |
| Designation |
Postgraduate resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia, VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi
A5, Tower 2, Type 5, GPRA Complex, Kidwai Nagar East, South West Delhi
South West
DELHI
110029
India |
| Phone |
8754717436 |
| Fax |
|
| Email |
vidyav1010@gmail.com |
|
|
Source of Monetary or Material Support
|
| VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi -110029 Country - India |
|
|
Primary Sponsor
|
| Name |
VMMC and Safdarjung Hospital |
| Address |
VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi0- 110029 Country - India |
| 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 Vidya V |
VMMC and Safdarjung Hospital |
VMMC and Safdarjung Hospital, Ansari Nagar West, New Delhi - 110029 Country - India
South West
DELHI |
8754717436
vidyav1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, VARDHMAN MAHAVIR MEDICAL COLLEGE AND SAFDARJUNG HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F319||Bipolar disorder, unspecified, (2) ICD-10 Condition: F22||Delusional disorders, (3) ICD-10 Condition: F429||Obsessive-compulsive disorder, unspecified, (4) ICD-10 Condition: F200||Paranoid schizophrenia, (5) ICD-10 Condition: F209||Schizophrenia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DEXMEDETOMIDINE |
Patients in the control group are given 10 ml normal saline IV. Patients in the dexmedetomidine group are given dexmedetomidine 0.25 mcg/kg IV diluted in 10 ml normal saline.Fasciculations are noted and graded using Mingus scale after administration of Succinylcholine. Myalgia is measured 30 mins after the procedure using self reported myalgia scores developed
by Harvey et al.
|
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Patients of the American Society of Anesthesiologists (ASA) physical status I/II aged 18–65 years undergoing ECT at VMMC and Safdarjung Hospital |
|
| ExclusionCriteria |
| Details |
Blind or deaf patients
Allergic to dexmedetomidine
Second- or third-degree heart block or persistent bradycardia
Taking beta blockers or other antiarrhythmic drugs
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Succinylcholine induced fasciculations
2. Succinylcholine induced myalgia 30 minutes after the procedure |
1. Succinylcholine induced fasciculations
2. Succinylcholine induced myalgia 30 minutes after the procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Hemodynamic parameters
- Heart rate
- Blood pressure and mean arterial pressure
- Oxygen saturation
before the procedure, during the procedure, 5 minutes,10 minutes and 20 minutes after the procedure. |
Hemodynamic parameters
- Heart rate
- Blood pressure and mean arterial pressure
- Oxygen saturation
before the procedure, during the procedure, 5 minutes,10 minutes and 20 minutes after the procedure. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
11/11/2025 |
| 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="6"
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
|
The study aims to investigate if Dexmedetomidine affects succinylcholine induced myalgia and fasciculations in psychiatric patients undergoing electroconvulsive therapy.Patients are randomly allocated into 2 groups - Group C (control) and group D(dexmedetomidine) using computer generated sequence. Patients are explained about grading of pain. Patients in the control group are given 10 ml normal saline IV. Patients in the dexmedetomidine group are given dexmedetomidine 0.25 mcg/kg IV diluted in 10 ml normal saline.Patients are shifted to the ECT room. Monitors are attached for continually monitoring heart rate, blood pressure, oxygen saturation. An IV line is secured. Patients in the dexmedetomidine group are given IV dexmedetomidine 0.25 mcg/kg diluted in 10 ml normal saline over 10 minutes. Patients in the control group are administered 10 ml normal saline.Patients are preoxygenated with 100% oxygen. Patients are administered Inj glycopyrrolate 0.2 mg IV. IV induction is done using Inj propofol 1 mg/kg IV and Inj succinylcholine 1.5 mg/kg IV. Fasciculations are noted and graded using Mingus scale. Patients are ventilated using bag and mask. An electrical stimulus is applied through the scalp electrodes after ensuring complete paralysis. Bag and mask ventilation is initiated after cessation of seizure activity in electroencephalogram until the patient’s spontaneous breathing is sufficient. Myalgia is measured 30 mins after the procedure using self reported myalgia scores developed by Harvey et al. Inj Paracetamol 1 g IV is given to patients with pain score of 2 or more (scale by Harvey et al).
|