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CTRI Number  CTRI/2024/07/070359 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 27/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the Effectiveness of Two different Reversal Agents in Reversing the Neuromuscular Paralysis by Muscle Relaxant in patients undergoing surgery under General anesthesia 
Scientific Title of Study   Comparative Efficacy Of Sugammadex Versus Neostigmine in Reversal Of Vecuronium Induced Moderate Neuromuscular Blockade in patients undergoing surgery under General anesthesia in a tertiary care hospital - A double blinded randomized controlled trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S SIVAKUMAR 
Designation  Professor and Head of the department  
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  9944060676  
Fax    
Email  siva85dr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  K PRIYANGA 
Designation  Assistant Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  8778365041  
Fax    
Email  priyapriyanga94@gmail.com  
 
Details of Contact Person
Public Query  
Name  K PRIYANGA 
Designation  Assistant Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014

Pondicherry
PONDICHERRY
605014
India 
Phone  8778365041  
Fax    
Email  priyapriyanga94@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences, Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014 
Type of Sponsor  Private medical college 
 
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 
Dr SIVAKUMAR S  Pondicherry Institute of Medical Sciences  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Kalathumethupathai, Ganapathichettikulam, Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 		 9944060676

siva85dr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine  50 µg/kg dose by intravenous route as a bolus over 10sec duration after the appearance of T2 count in Train of Four count at the end of surgery 
Intervention  Sugammadex  2 mg/kg dose by intravenous route as a bolus over 10sec duration after the appearance of T2 count in Train of Four count at the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patients aged between 18 to 60yrs, Patients belonging to ASA class I and II 
 
ExclusionCriteria 
Details  1) Significant kidney disease (stage 4 kidney disease or higher), Significant liver disease (aspartate aminotransferase [AST] or
alanine aminotransferase[ALT] more than twice the upper limit of normal), Emergency surgeries under general anaesthesia, Patients requiring post operative mechanical ventilation, Difficult airway, Pregnancy/Breastfeeding, Known case of neuromuscular disorder, Allergies to study drugs 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the incidence of post operative residual neuromuscular paralysis with
sugammadex or neostigmine during vecuronium induced moderate neuromuscular blockade with Train of Four (TOF) monitoring in patients undergoing surgery under general anesthesia 		 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time from the start of administration of sugammadex or neostigmine to
recovery of the Train of Four (TOF) ratio to 0.9 		 1 year 
To compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow
rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak
expiratory flow rate (PEFR) after arrival to Post anaesthesia care unit (PACU) 		 1 year 
To record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU)  1 year 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   Phase 4 
Date of First Enrollment (India)   01/08/2024 
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="0"
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   This study is a randomised, double blinded, controlled trial comparing the efficacy of Sugammadex Versus Neostigmine in Reversal Of Vecuronium Induced Moderate Neuromuscular Blockade in patients undergoing surgery under General anesthesia in a tertiary care hospital on 84 participants. The primary objective is to compare the incidence of post-operative residual neuromuscular paralysis with sugammadex or neostigmine during vecuronium induced moderate neuromuscular blockade with Train of Four (TOF) monitoring in patients undergoing surgery under general anesthesia. The secondary objective is to compare the time from the start of administration of sugammadex or neostigmine to recovery of the Train of Four (TOF) ratio to 0.9 , to compare the baseline Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) values and post-operative Forced expiratory volume (FEV1) and Peak expiratory flow rate (PEFR) after arrival to Post anaesthesia care unit (PACU) and to record adverse events in both the groups until discharge from Post anaesthesia care unit (PACU) 
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