| CTRI Number |
CTRI/2025/08/092279 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Magnesium and Ketamine to Prevent Muscle Twitches and Pain After Succinylcholine in Patients Undergoing Surgery |
|
Scientific Title of Study
|
Comparison of Prophylactic Intravenous magnesium versus ketamine on Succinylcholine-Induced Fasciculations and Postoperative Myalgia in Patients Undergoing Elective Surgery under General Anaesthesia |
| 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 Shashi Yadav |
| Designation |
Junior Resident |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9565580233 |
| Fax |
|
| Email |
thatsmeshashi2403@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashita Mowar |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS) |
| Address |
Department of Anaesthesia , Shri Ram Murti Smarak Institute of Medical Sciences (SRMS IMS)
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9568578724 |
| Fax |
|
| Email |
drash.royals@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Ram Murti Smarak Institute of Medical Sciences, Bhojipura, Bareilly, Uttar Pradesh 243202 |
|
|
Primary Sponsor
|
| Name |
SRMS IMS |
| Address |
Ram Murti Puram, 13KM, Bareilly - Nainital Rd, Bhoji Pura, Abheypur Keshonpur, Uttar Pradesh 243202 |
| 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 Shashi Yadav |
Shri Ram Murti Smarak Institute of Medical Sciences |
OT Complex, Department of Anaesthesia, Shri Ram Murti Smarak Institute of Medical Sciences
Bareilly
UTTAR PRADESH |
9565580233
thatsmeshashi2403@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ELECTIVE SURGERIES FOR ASA GRADE I AND II |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous Ketamine (0.5 mg/kg) |
Group B - 64 subjects will be administered 0.5 mg/kg ketamine diluted in 100 ml NS over 10 minutes. |
| Intervention |
Intravenous Magnesium Sulphate (40 mg/kg) |
Group A - 64 subjects will be administered with 40 mg/kg magnesium sulphate in 100 ml NS, infused in 10 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status I/II.
Patients undergoing elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Emergency cases
Contraindication to succinylcholine
History of neuromuscular disease
Patients taking calcium channel blockers, B – blockers
Systemic disease – HTN, DM
Substance abuse
Hyperkalemia
Allergic to study drugs.
Patients requiring post operative ICU ventilation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of intravenous magnesium sulphate on succinylcholine - induced fasciculations and postoperative myalgia in patients undergoing elective surgery under general anesthesia.
To evaluate the efficacy of intravenous ketamine on succinylcholine - induced fasciculations and postoperative myalgia in patients undergoing elective surgery under general anesthesia. |
The incidence and severity of succinylcholine induced fasiculations will be observed soon after its administeration and postoperative myalgia will be determined at 0 hour, 6 hour, 12 hour, 24 hour, and 48 hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the effect of intravenous magnesium sulphate and ketamine in succinylcholine - induced fasciculations and postoperative myalgia.
To observe the adverse effect associated with the study drugs. |
The incidence and severity of succinylcholine induced fasiculations will be observed soon after its administeration and postoperative myalgia will be determined at 0 hour, 6 hour, 12 hour, 24 hour, and 48 hour. |
|
|
Target Sample Size
|
Total Sample Size="128"
Sample Size from India="128"
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)
|
20/08/2025 |
| 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
|
To compare the effect of intravenous magnesium sulphate and ketamine in succinylcholine - induced fasiculations and postoperative myalgia in patients undergoing elective surgery under general anaesthesia. |