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CTRI Number  CTRI/2026/03/106125 [Registered on: 13/03/2026] Trial Registered Prospectively
Last Modified On: 12/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study comparing two medicines (Sugammadex vs. Neostigmine) to see which works better and faster at stopping the effects of a muscle relaxant drug in adults having planned surgery 
Scientific Title of Study   EFFICACY OF SUGAMMADEX VERSUS NEOSTIGMINE FOR REVERSAL OF ROCURONIUM-INDUCED NEUROMUSCULAR BLOCKADE IN ADULTS UNDERGOING ELECTIVE SURGERY: A RANDOMISED CONTROLLED STUDY 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhjit Singh Pahwa 
Designation  Senior Consultant   
Affiliation  Institute of Anaesthesiology, Pain and Perioperative Medicin 
Address  Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.  

Central
DELHI
110060
India 
Phone  9650140022  
Fax    
Email  drabhjit@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhjit Singh Pahwa 
Designation  Senior Consultant   
Affiliation  Institute of Anaesthesiology, Pain and Perioperative Medicin 
Address  Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.  

Central
DELHI
110060
India 
Phone  9650140022  
Fax    
Email  drabhjit@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Thangasiva P 
Designation  DNB Postgraduate Trainee 
Affiliation  Institute of Anaesthesiology, Pain and Perioperative  
Address  Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.  

Central
DELHI
110060
India 
Phone  9677201131  
Fax    
Email  goldsivawillwin@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital 
Address  Sir Ganga Ram Hospital,Rajinder Nagar, New Delhi-110060, India.    
Type of Sponsor  Research institution and hospital 
 
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 Abhjit Singh Pahwa  Sir Ganga Ram Hospital  OT11 7TH FLOOR SSRB BLOCK institute of anaesthesiology pain and perioperative medicine SGRH new delhi
Central
DELHI 
96501 40022

drabhjit@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, SGRH  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 
Intervention  NA  NA 
Comparator Agent  Neostigmine group  At the end of surgery, neuromuscular blockade will be reversed using neostigmine 50 microgram/kg (mcg/kg) along with glycopyrrolate 10 mcg/kg body weight (a premixed colourless drug in a 5ml ampoule contains 2.5mg of neostigmine and 0.5 mg of glycopyrrolate) when the neuromuscular monitor indicates a train-of-four count of 3. 
Comparator Agent  Sugammadex group  At the end of surgery, neuromuscular blockade will be reversed using sugammadex 2 mg/kg body weight (2ml vial contains 100mg/ml of drug which is colourless) when the neuromuscular monitor indicates a train-of-four count of 3. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I and II
Duration of surgery is less than 2 hours 
 
ExclusionCriteria 
Details  Patients refusing to participate in the study
Patients with known neuromuscular disorders
Patients undergoing organ transplant surgery emergency procedures and patients needing intensive care admission in the postoperative period
Obese patients with a body mass index BMI greater than 30kg/m2
Renal or hepatic dysfunction
Women taking oral contraceptives
Pregnant patients
Allergy to drugs under study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time required to achieve the quantitative neuromuscular monitoring endpoint (TOFR 0.9) following the administration of the reversal agents under investigation  At time of giving reversal agent
When TOFR reached 0.9

 
 
Secondary Outcome  
Outcome  TimePoints 
patients having bronchospasm, tachypnea with respiratory rate greater than 24 per min, SpO2 less than 92 % at room air during the first 60 min after extubation, in the PACU.
patients requiring airway support (viz. airway opening manoeuvres, oral or nasal airway insertion, CPAP / BiPAP, endotracheal intubation) during the first 60 min after extubation, in the PACU.
patients having heart rate greater than 100/min or less than 60/min, systolic blood pressure plus minus 20% of baseline, diastolic blood pressure plus minus 20% of baseline, and mean blood pressure plus minus 20% of baseline, after administration of reversal agent, continuing to PACU for the first 60 min post-extubation.
 
till 60 mins after extubation 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   17/03/2028 
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 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  

Reversal of neuromuscular blockade (NMB) is essential for optimal recovery following general anaesthesia. Neostigmine has long served as the conventional agent for this purpose; however, sugammadex a novel cyclodextrin compound specifically engineered to counteract rocuronium-induced NMB has demonstrated promising advantages in terms of speed and reliability. Although both agents facilitate reversal of rocuronium, their comparative efficacy and safety profiles remain subjects of ongoing clinical scrutiny, particularly when assessed using train-of-four (TOF) neuromuscular monitoring.

This  randomized controlled trial is designed to evaluate the efficacy of sugammadex versus neostigmine for reversing  rocuronium-induced NMB in adult patients undergoing elective surgical procedures under general anaesthesia. TOF monitoring will be employed to ensure objective and quantifiable assessment of efficacy of neuromuscular recovery as determined by the time to achieve the primary outcome.

A total of 100 adult patients who meet eligibility criteria and provide informed consent will be enrolled. The primary outcome is the time required to achieve a TOF ratio (TOFR) of  gretaer than  0.9 after administration of reversal agent. Secondary outcomes include the incidence of adverse respiratory events in the post-anaesthesia care unit (PACU) till 60 minutes after extubation, as well as perioperative changes in hemodynamic parameters, namely, heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP).

While international literature consistently supports the superior efficacy of sugammadex over neostigmine in reversing rocuronium-induced NMB,  to the best of our knowledge, there is no study in the Indian population. To address this gap, our study seeks to generate contextually relevant evidence.

 
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