| CTRI Number |
CTRI/2025/09/095354 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Magnesium Sulphate Pre-treatment: Enhancing the Onset and Recovery of Muscle Relaxants with Neuromuscular Monitoring |
|
Scientific Title of Study
|
Pre treatment with Magnesium sulphate Before Non-depolarizing Muscle Relaxants; Effect on speed of onset and recovery using Neuromuscular Monitoring |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syed Noor Mohammed |
| Designation |
Junior Resident |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences and Research centre,
Department of Anaesthesiology Division - Anaesthesiology
Room number :OT 1,2 and 3 ground floor
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Bangalore
KARNATAKA
560090
India |
| Phone |
8095927286 |
| Fax |
|
| Email |
syednoor306@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabha P |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences and Research centre,
Department of Anaesthesiology Division - Anaesthesiology
Room number :OT 1,2 and 3 ground floor
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Bangalore
KARNATAKA
560090
India |
| Phone |
9448055973 |
| Fax |
|
| Email |
prabhap1510@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabha P |
| Designation |
Professor |
| Affiliation |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
Sapthagiri Institute Of Medical Sciences and Research centre,
Department of Anaesthesiology Division - Anaesthesiology
Room number :OT 1,2 and 3 ground floor15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
Bangalore
KARNATAKA
560090
India |
| Phone |
9448055973 |
| Fax |
|
| Email |
prabhap1510@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sapthagiri Institute Of Medical Sciences And Research Centre, Bangalore
560090
Karnataka |
|
|
Primary Sponsor
|
| Name |
Sapthagiri Institute Of Medical Sciences And Research Centre |
| Address |
SapthagiriInstitute Of Medical Sciences and Research Centre
Department of Anaesthesiology
Division- Anaesthesiology
Room number:OT 1,2 and 3 Ground floor
15,Hesaraghatta road,Navy layout,Sapthagiri Institute Of Medical Sciences And Research Centre
560090
Bangalore
Karnataka |
| 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 |
| Syed Noor Mohammed |
Sapthagiri Institute Of Medical Sciences And Research Centre |
SapthagiriInstituteOfMedicalSciencesAndResearchCentre
Department of Anaesthesiology
Division- Anaesthesiology
Room number : OT 1,2 and 3 Ground floor,15 Hesarghatta Rd, Chikkabanavara, Bangalore
Bangalore
KARNATAKA |
8095927286
syednoor306@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sapthagiri Institute Of Medical Sciences And Research Centre 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 |
| Intervention |
Magnesium Sulphate 50mg/kg |
Magnesium Sulphate 50mg/kg over 10 minutes before induction
The Heart ,Blood pressure will be assessed at interval of before induction, just after intubation,5 min,30 min,60 min,before reversal,after extubation,5 min |
| Comparator Agent |
Ringer lactate |
Ringer lactate with same volume and infusion rate as intervention group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients undergoing elective surgeries under GA
2.ASA grade 1and 2
3.Informed consent
4.BMI 18-28 kg/m2
5.All non cardiac surgery
|
|
| ExclusionCriteria |
| Details |
1.on sedatives /hypnotic pre operatively
2.Allergy to study drug
3.Psychiatric illness |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the effect of Magnesium Sulphate pre-treatment on onset and duration recovery of neuromuscular blockade |
vitals will be monitored at before induction, just after intubation, 5min,30min,60min and before reversal and after extubation and 5 min after extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
09/10/2025 |
| 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="0"
Months="3"
Days="0" |
|
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 - NO
|
|
Brief Summary
|
Laryngoscopy and tracheal intubation trigger sympathetic surges Magnesium sulphate blunts catecholamine release and is widely used for hemodynamic control and as an anticonvulsant At the neuromuscular junction Magnesium Sulphate inhibits presynaptic acetylcholine release and can potentiate non depolarizing neuromuscular blockers Magnesium sulphate decreases the need for anesthesia shortens the time needed for propofol to induce anaesthesia and decreases the overall amount of postoperative analgesics used without having any negative effects on the mother or the unborn child The potential of magnesium sulphate to enhance neuromuscular blockade has been suggested but requires confirmation through direct neuromuscular monitoring studies |