| CTRI Number |
CTRI/2025/11/097565 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Dexmedetomidine for reducing succinylcholine indused myalgia in patients undergoing Electroconvulsive therapy. |
|
Scientific Title of Study
|
"To Evaluate Efficacy of Dexmedetomidine for Reducing Sucicnylcholine Induced Myalgia in Patients undergoing Electro convulsive Therapy." |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| S9966/A |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUCHETA SUHAS DOSHI |
| Designation |
JOUNIOR RESIDENT |
| Affiliation |
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat. |
| Address |
DHIRAJ HOSPITAL SUMANDEEP VIDHYPEETH WAGHODIYA VADODARA GUJRAT
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
7083512180 |
| Fax |
|
| Email |
suhasdoshi2014@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SARA MARRY THOMAS |
| Designation |
HOD and Profesor Department of anaesthesia |
| Affiliation |
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat. |
| Address |
DHIRAJ HOSPITAL SUMANDEEP VIDYAPEETH PIPARIYA VADODARA GUJARAT
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat.
Pin code-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr SARA MARRY THOMAS |
| Designation |
HOD and Profesor Department of anaesthesia |
| Affiliation |
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat. |
| Address |
DHIRAJ HOSPITAL SUMANDEEP VIDYAPEETH PIPARIYA VADODARA GUJARAT
Pin code 391760
Smt Bhailal Kothari Shah Medical Institute and Research Centre Vadodara, Gujarat.
Pin code- 391760
Vadodara
GUJARAT
391760
India |
| Phone |
9646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhiraj Hospital Sumandeep vidyapeeth |
| Address |
SUMANDEEP VIDHYPEETH Pipariya Waghodiya, VADODARA GUJRAT
Pin code-391760 |
| 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 |
| DR SARA MARRY THOMAS |
Dhiraj Hospital |
4th floor ECT room, department of Anaesthesia, SUMANDEEP VIDHYPEETH WAGHODIYA, VADODARA GUJRAT
Vadodara
GUJARAT |
96465 00158
sara.cinosh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep vidyapeeth institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
Comparator group will recieve 100 ml Normal Saline intravenously 10 minutes before electro convulsive therapy |
| Intervention |
Group D |
Interventional group will recieve low dose dexmeditomidine (0.25 mcg per kg) diluted in 100 ml Normal Saline given intravenously over 10 minutes before electrocounvulsive therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to sign informed consent.
Patient belonging to ASA physical status 1 and 2.
Patients undergoing Electroconvulsive therapy. |
|
| ExclusionCriteria |
| Details |
Patients unwilling to participate in study.
Patient with BMI more than 30 kg/m2.
Patient who are deaf or incapable of understanding the language.
Patient belonging to ASA physical status 3.
Patients with history of allergy to an adrenergic agonist.
Pregnancy and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This prospective study will help us to evaluate the efficacy of low dose intravenous Dexmedetomidine in reducing fasciculations and myalgia due to sucicnylcholine during electro convulsive therapy. |
This prospective study will help us to evaluate the efficacy of low dose intravenous Dexmedetomidine in reducing fasciculations immediately after giving Sccinylcholine and myalgia due to sucicnylcholine after 60 minutes of electro convulsive therapy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Dexmedetomidine in attenuating blood pressure & heart rate during electro convulsive therapy. |
At Base line, 5 min after drug intervention, During ECT, 3 min, 5 min, 10 min, 20 min, 30 min after ECT |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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
|
In the present study we will be comparing the efficacy of low dose of intravenous Dexmedetomidine (0.25 mcg/ kg) diluted in 100 ml Normal Saline for reducing incidence and severity of sucicnylcholine induced myalgia and fascination and optimization of hemodynamics in patients undergoing electro convulsive therapy. |