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CTRI Number  CTRI/2025/10/096704 [Registered on: 31/10/2025] Trial Registered Prospectively
Last Modified On: 29/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of time taken by two drugs - Sugammadex and Neostigmine to reverse the effect of vecuronium induced neuromuscular blockade in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia: a randomized clinical trial. 
Scientific Title of Study   Comparison of Sugammadex and Neostigmine on the reversal of vecuronium induced neuromuscular blockade in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia- a randomized clinical 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  LALAN SINGAM 
Designation  POST GRADUATE TRAINEE 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology and Critical Care, Regional Institute of Medical Sciences, Imphal West District, Manipur

Imphal West
MANIPUR
795004
India 
Phone  7005846859  
Fax    
Email  LALANSINGAM9@GMAIL.COM  
 
Details of Contact Person
Scientific Query  
Name  TAKHELMAYUM HEMJIT SINGH 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology and Critical Care, Regional Institute of Medical Sciences, Imphal West District, Manipur

Imphal West
MANIPUR
795004
India 
Phone  9436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Details of Contact Person
Public Query  
Name  TAKHELMAYUM HEMJIT SINGH 
Designation  ASSOCIATE PROFESSOR 
Affiliation  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology and Critical Care, Regional Institute of Medical Sciences, Imphal West District, Manipur

Imphal West
MANIPUR
795004
India 
Phone  9436021445  
Fax    
Email  takhelhem@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Imphal West District, Manipur, India-795004 
 
Primary Sponsor  
Name  Regional Institute of Medical Sciences 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences, Lamphelpat, Imphal West District, Manipur  
Type of Sponsor  Government 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 Lalan Singam  Regional Institute of Medical Sciences  Operation Theatre Complex Department of Anaesthesiology Regional Institute of Medical Sciences Imphal Imphal West Manipur
Imphal West
MANIPUR 		 8119044047

lalansingam9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Boards, Regional Institute of Medical Sciences, Imphal, Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj. Neostigmine 50mcg/kg( maximum of 5mg) with Inj. Glycopyrrolate 10mcg/kg  Study participants will receive Inj. Neostigmine 50mcg/kg( maximum of 5mg) with Inj. Glycopyrrolate 10mcg/kg diluted in 10mL of normal saline as reversal for vecuronium induced neuromuscular blockade when four twitches to train of four stimulation appear. 
Intervention  Inj. Sugammadex 2mg/kg  Study participants will receive Inj. Sugammadex 2mg/kg diluted in 10mL normal saline for reversal of vecuronium induced neuromuscular blockade when four twitches to train of four stimulation appear.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients of either sex-male or female
2. Patients of age group 18 to 60 years of Manipuri ethnicity undergoing elective laparoscopic cholecystectomy surgery under general anaesthesia.
3. Patients of American Society of Anesthesiologists (ASA) physical status grade I or II 
 
ExclusionCriteria 
Details  1. Patients not willing to participate
2. Patients with known allergy to any of the study drugs
3. Patients with known neuromuscular disease.
4. Patients with pre-existing respiratory, cardiovascular, hepatic or renal dysfunction.
5. Patients with suspected malignant hyperthermia
6. Pregnant and breastfeeding patients
7. Patient who had joined in any studies in the past one month.

 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Time taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more.
2. Time to 5 secs head lift from the time of administration of the study drugs. 		 1. Time (mins) taken from the start of administration of the study drugs (Sugammadex or Neostigmine-Glycopyrrolate) at appearance of fourth twitch of train of four stimulation till recovery of normalized TOF ratio of 0.9 or more( single time point)
2. Time (mins) to 5 secs head lift from the start of administration of the study drugs( single time point). 
 
Secondary Outcome  
Outcome  TimePoints 
1. Hemodynamic parameters such as blood pressure(BP) & heart rate (HR).
2. Incidences of train of four normalized ratio of less than 0.9 during the first hour of post-operative period. 		 1.Hemodynamic parameters such as BP & HR ( baseline, at 5min, 10mins, thereafter, every 10 mins until OT is done & every 15min till 1 hour of the post-operative period).
2.Incidences of train of four normalized ratio of less than 0.9 during the 1st hour of the post-operative period. 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   23/11/2025 
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="1"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [lalansingam9@gmail.com].

  6. For how long will this data be available start date provided 23-11-2025 and end date provided 09-10-2027?
    Response - Immediately following publication. No end date.

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

This randomized, double blinded clinical trial will be conducted to compare sugammadex and neostigmine for the reversal of vecuronium induced neuromuscular blockade in 36 patients of ASA I or II aged 18 to 60 years, of both sexes, of Manipuri Ethnicity undergoing elective laparoscopic cholecystectomy under general anaesthesia in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur.

The patients will be randomly divided into two groups (Group A and Group B) of 18 participants each.  Group A patients will receive 10 ml of Inj. Sugammadex 2mg/kg and Group B patients will receive 10 ml of Inj. Neostigmine 50mcg/kg (to a maximum of 5mg) plus glycopyrrolate 10mcg/kg when four twitches to train of four stimulation appear. The time taken from the start of administration of the study drugs at appearance of fourth twitch of train of four stimulation to its normalised ratio of 0.9 and time taken to attain 5 sec head lift from the administration of the study drugs will be compared for the two groups. Additionally, hemodynamic parameters and side effects, if any, will be assessed.

All the findings and observations made during the entire study will be tabulated, graphically depicted wherever possible, statistically analyzed and inference will be drawn to evaluate and compare the two drugs with their clinical advantages and side effects.

 
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