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CTRI Number  CTRI/2024/03/064171 [Registered on: 15/03/2024] Trial Registered Prospectively
Last Modified On: 31/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the effects of sugammadex and neostigmine as an effective reversal agent for muscle relaxation in children undergoing abdominal and urogenital surgeries under general anaesthesia .  
Scientific Title of Study   Comparative analysis of sugammadex versus neostigmine as an effective reversal agent in paediatric abdominal and urogenital surgeries under general anaesthesia. A randomised control 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  Preeti Prasasya Sahoo 
Designation  Junior resident 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Super Speciality MOT complex , 4th Floor, B Block, All India Institute of Medical Science Tatibandh

Raipur
CHHATTISGARH
492099
India 
Phone  8260162030  
Fax    
Email  psahu9762@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Subrata Kumar Singha  
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of anesthesiology, B Block , 4th floor All India Institute of medical sciences, Tatibandh Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8518881767  
Fax    
Email  subratsingh@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr. Subrata Kumar Singha 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, Raipur 
Address  Department of Anesthesiology, B Block, 4th floor All India Institute of medical sciences Tatibandh Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8260162030  
Fax    
Email  subratsingh@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Raipur  
 
Primary Sponsor  
Name  AIIMS  
Address  AIIMS Raipur  
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 Preeti Prasasya Sahoo  All India Institute of Medical Sciences, Raipur  Pediatric OT, Department of Anesthesiology, B Block MOT, 4th floor All India Institute of Medical Sciences Raipur 492099
Raipur
CHHATTISGARH 		 8260162030

psahu9762@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee AIIMS Raipur   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  Injection Neostigmine 0.05mg per kg body weight along with Injection Glycopyrrolate 0.01mg per kg body weight single dose slow iv to be administered at the reappearance of T2 on train of four stimulation after completion of surgery and to look for time taken for complete reversal and extubation.  
Intervention  Sugammadex   Injection Sugammadex 2mg per kg body weight single dose slow iv to be administered at the reappearance of T2 on train of four stimulation after completion of surgery and to look for time taken for complete reversal and extubation. 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Abdominal surgeries
Urogenital surgeries
ASA 1&2
General anaesthesia  
 
ExclusionCriteria 
Details  Not willing for consent
Developmental delay
Known history of drug allergy
Diseases affecting neuromuscular junction or malignant hyperthermia
Kidney / liver failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Time from start of administration of sugammadex/ neostigmine to recovery of the T4/T1 ratio to 0.9  At reappearance of T2 
 
Secondary Outcome  
Outcome  TimePoints 
Number of participants with clinical signs of recovery assessed by GCS and MRC.  At intervals of 15 mins, 30 mins, 1 hr and 2 hrs in Post anaesthesia care unit. 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   25/03/2024 
Date of Study Completion (India) 05/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 05/05/2025 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
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 randomised control study will compare the effectiveness and adverse effects of the two reversal agents sugammadex and neostigmine for reversing neuromuscular blockade induced with rocuronium undergoing abdominal and urogenital surgeries under general anaesthesia. Paediatric patients between age 2-12 years will be divided into two groups and both groups to be given rocuronium as muscle relaxant and after completion of surgery TOF monitoring should be done to assess the neuromuscular blockade and one of the two reversing agents to be used in each group and time to recovery of neuromuscular block and adverse effects compared. Also the GCS and MRC will be compared in the post operative period to compare the efficacies of each drug. 
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