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CTRI Number  CTRI/2025/09/095120 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On: 12/09/2025
Post Graduate Thesis  No 
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 and Neostigmine, used to help patients wake up safely after anesthesia 
Scientific Title of Study   Comparing Sugammadex with Neostigmine for reversal of rocuronium-induced neuromuscular blockade: a randomized 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  Dharitri Dutta 
Designation  DNB trainee 
Affiliation  Indraprastha Apollo Hospital, New Delhi 
Address  Department of Anaesthesiology,
Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India 
Phone  09508033371  
Fax    
Email  dharitridutta89@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vikram Mahajan 
Designation  Senior Consultant 
Affiliation  Indraprastha Apollo Hospital, New Delhi 
Address  Department of Anaesthesiology,
Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India 
Phone  9818518876  
Fax    
Email  vikram007mahajan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dharitri Dutta 
Designation  DNB trainee 
Affiliation  Indraprastha Apollo Hospital, New Delhi 
Address  Department of Anaesthesiology,
Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India 
Phone  09508033371  
Fax    
Email  dharitridutta89@gmail.com  
 
Source of Monetary or Material Support  
Indraprastha Apollo Hospital, Sarita Vihar, New Delhi, India- 110076 
 
Primary Sponsor  
Name  Indraprastha Apollo Hospital, New Delhi 
Address  Sarita Vihar, New Delhi-110020 
Type of Sponsor  Private hospital/clinic 
 
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 
DHARITRI DUTTA  Indraprastha Apollo Hospital  Department of Anaesthesiology, First Floor, OT Complex, Indraprastha Apollo Hospital, Sarita Vihar, New Delhi
New Delhi
DELHI 		 09508033371

dharitridutta89@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-BMR, Indraprastha Apollo Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z018||Encounter for other specified special examinations,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Neostigmine with Glycopyrrolate  Dosage: Neostigmine 0.05 mg/kg IV + Glycopyrrolate 0.01 mg/kg IV Route: Intravenous (IV) Frequency: Single dose at the end of surgery for reversal of rocuronium-induced neuromuscular blockade Duration: One-time administration during procedure Additional details: Administered after discontinuation of anesthetic agents and at recovery from neuromuscular block 
Intervention  Sugammadex  Dosage: 2 mg/kg IV bolus (adjusted according to actual body weight, given at reappearance of T2 in TOF monitoring) Route: Intravenous (IV) Frequency: Single dose at the end of surgery for reversal of rocuronium-induced neuromuscular blockade Duration: One-time administration during procedure Additional details: Administered after discontinuation of anesthetic agents and at recovery from neuromuscular block 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  ASA (American Society of Anaesthesiologists), physical status 1 and 3
Age more than 18 years
Any surgical procedure under general anesthesia with rocuronium and requiring reversal 
 
ExclusionCriteria 
Details  Hypersensitivity to any drugs/cyclodextrins
Difficult intubation
Neuromuscular disorder/neurodegenerative disorders
Severe renal and hepatic dysfunction
History of Malignant hyperthermia
Pregnancy
Chronic obstructive airway disease
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time required to reach train of four ratio to 0.9 after the administration of sugammadex or neostigmine  Every 15 minutes till TOF more than equal to 0.9 and at 2 hours after extubation 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative residual paralysis,
Adverse effects of neostigmine and sugammadex 		 At 2 hours after extubation 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   23/09/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dharitridutta89@gmail.com].

  6. For how long will this data be available start date provided 05-01-2026 and end date provided 05-01-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

In this study, we will compare the safety and efficacy of sugammadex over neostigmine for the reversal of rocuronium-induced neuromuscular block.  We also intend to assess the risk of postoperative residual paralysis and adverse effects of neostigmine and sugammadex.

 
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