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CTRI Number  CTRI/2025/11/097036 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 05/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study Comparing how well a new Drug (Sugammadex) helps patients wake up from Muscle Relaxants when they’ve been given Magnesium sulphate before surgery 
Scientific Title of Study   A clinical double-blind randomized controlled study comparing the efficacy of Sugammadex in reversing Vecuronium-induced neuromuscular blockade in patients pretreated with Magnesium Sulphate(MgSO4). 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nilaoli A 
Designation  Junior Resident 
Affiliation  Subharti Medical College and Hospitals 
Address  Department of Anaesthesiology and Critical care, 2nd floor chhatrapati Shivaji Subharti Hospital, Subharti University, NH58 Delhi Haridwar Bypassroad, Meerut.

Meerut
UTTAR PRADESH
250005
India 
Phone  9361111930  
Fax    
Email  nilavoli95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vivek Maratha 
Designation  Professor 
Affiliation  Subharti Medical College and Hospitals 
Address  Department of Anaesthesiology and critical care, 2nd floor, Chhatrapati Shivaji Subharti Hospital, Subharti UNiversity, NH58 Delhi Haridwar Bypassroad, Meerut.

Meerut
UTTAR PRADESH
250005
India 
Phone  9837035415  
Fax    
Email  drvivekmaratha@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr. Vivek Maratha 
Designation  Professor 
Affiliation  Subharti Medical College and Hospitals 
Address  Department of Anaesthesiology and critical care medicine, 2nd floor, Chhatrapati Shivaji Subharti Hospital, Subharti University, NH58 Delhi Haridwar Bypassroad, Meerut, UP.

Meerut
UTTAR PRADESH
250005
India 
Phone  9837035415  
Fax    
Email  drvivekmaratha@yahoo.com  
 
Source of Monetary or Material Support  
Chhatrapti Shivaji Subharti Hospital, Subharti Medical College, Subharti University, NH 58, Delhi Haridwar Bypass road , SUbhartipuram, Meerut , Uttar Pradesh - 250005, India. 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [Nil] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Nilaoli A  Chhatrapati Shivaji Subharti Hospital  1st floor and 2nd floor OT complex, Department of Anaesthesiology and Critical Care, Subharti University, NH58, Delhi Haridwar Bypass road, Subhartipuram.
Meerut
UTTAR PRADESH 		 9361111930

nilavoli95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
UNIVERSITY ETHICS COMMITTEE (MEDICAL) SWAMI VIVEKANAND SUBHARTI UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Action of Magnesium Sulphate on neuromuscular blockade and reversal agent  Inj. Magensium Sulphate 40mg/kg in 100ml NS 30minutes before surgery Inj. Vecuronium 0.1mg/kg during the time of induction Inj. Sugammadex 2mg/kg during the time of Reversal 
Comparator Agent  Normal Saline  Normal Saline 100ml will be administered to control group 30 minutes before the surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade 1 and 2 
 
ExclusionCriteria 
Details   
 
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 compare and evaluate the efficacy of pre-treatment with Magnesium
Sulphate vs Normal saline in Vecuronium-induced neuromuscular blockade
(train-of four (TOF) more than 0.9) on the time of reversal with Sugammadex. 		 The time taken to reach a train-of-four (TOF) ratio greater than 0.9 after administering Sugammadex. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the post-operative complication of both groups  5 minutes post op
10 minutes post op
20 minutes post op
30 minutes post op 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/12/2025 
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="2"
Months="0"
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   This prospective, double blind, randomized controlled study will be conducted to evaluate the efficacy of sugammadex in reversing vecuronium-induced neuromuscular blockade in patients who will be pretreated with magnesium sulphate . Eligible adult patients undergoing elective surgical procedures under general anesthesia will be randomly allocated into two groups. The study group will receive intravenous Magnesium Sulphate at a dose of 60 mg per kg before induction, while the control group will receive an equal volume of normal saline. Anesthesia will be induced with propofol and an opioid, followed by vecuronium 0.1 mg/kg to achieve adequate muscle relaxation. Continuous neuromuscular monitoring using Train of Four  stimulation will be utilized throughout the procedure. When the second twitch of the TOF reappears, sugammadex will be administered intravenously at a dose of 2 mg per kg . The primary endpoint will be the time from administration of sugammadex to recovery of a TOF ratio of 0.9 or greater, while secondary outcomes will include hemodynamic stability and occurrence of any adverse effects. This study will aim to determine whether pretreatment with magnesium sulphate influences the speed or effectiveness of reversal of vecuronium induced neuromuscular block by sugammadex. 
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