| CTRI Number |
CTRI/2025/12/099914 [Registered on: 29/12/2025] Trial Registered Prospectively |
| Last Modified On: |
27/12/2025 |
| 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
|
To study how the fasciculations and post operative myalgia caused by Succinylcholine is being reduced by using Rocuronium |
|
Scientific Title of Study
|
To study the effect of precurarization with optimal dose of rocuronium on the incidence of succinylcholine induced fasciculations and myalgia. |
| 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 HARSHINI T |
| Designation |
POST GRADUATE |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
Room number 14, Vinayaka missions kirupanandha variyar medical college and hospital
Room number 14, Vinayaka missions kirupanandha variyar medical college and hospital
Salem
TAMIL NADU
606308
India |
| Phone |
9884965164 |
| Fax |
|
| Email |
harshini.thirumoorthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUN KUMAR B |
| Designation |
PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 14
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPIAL
SALEM
ROOM NUMBER 14
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPIAL
SALEM
Salem
TAMIL NADU
606308
India |
| Phone |
9884965164 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUN KUMAR B |
| Designation |
PROFESSOR |
| Affiliation |
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 14
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPIAL
SALEM
ROOM NUMBER 14
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPIAL
SALEM
Salem
TAMIL NADU
606308
India |
| Phone |
9884965164 |
| Fax |
|
| Email |
cruise2010.mmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROOM NUMBER 14
VINAYAKA MISSIONS KIRUPANANDHA VARIYAR MEDICAL COLLEGE AND HOSPITAL
SALEM 636308
|
|
|
Primary Sponsor
|
| Name |
vinayaka missions kirupanandha variyar medical college and hospital |
| Address |
Room number 14, Vinayaka missions kirupanandha variyar medical college and hospital, chinnaseragapadi, salem 606308 |
| 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 Harshini |
Vinayaka missions kirupanandha variyar medical college and hospital |
Room number 15
vinayaka missions kirupanandha vaiyar medical college andhospital
chinnaseragapadi salem 636308
Salem
TAMIL NADU |
9884965164
harshini.thirumoorthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Vinayaka missions Kirupanandha Variyar Medical College and Hospitals Salem |
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 |
| Intervention |
Rocuronium |
Precurarization dose of Rocuronium 0.04mg/kg IV is given 30 seconds prior to Succinylcholine 2mg/kg IV during to intubation |
| Comparator Agent |
Succinylcholine |
Succinylcholine 2mg/kg IV given prior to intubation |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving valid consent
ASA 1 and 2
Elective surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal
ASA 3 and 4
Emergency surgeries
Patients having chronic pain and on medications for spasticity
Patients with ischemic heart disease
Patients with neurologic illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE EFFECT OF PRECURARIZATION WITH OPTIMAL DOSE OF ROCURONIUM ON THE INCIDENCE OF SUCCINYLCHOLINE INDUCED FASCICULATIONS AND MYALGIA |
baseline, post operative day 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO STUDY THE EXTENT AND SEVERITY OF FASCICULATIONS AND MYALGIA |
POST OPERATIVE UPTO 24HOURS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
07/01/2026 |
| 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="0"
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
|
To help in studying how a prior doze of Rocuronium before Succinylcholine during induction helps to reduce the amount of fasciculations and myalgia postoperatively to help in grading the severity of fasciculations and myalgia in the groups with and without a prior precurarization with Rocuronium |