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CTRI Number  CTRI/2025/03/083118 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the time taken for reversal of neuromuscular blockade in patients undergoing general anaesthesia with either sugammadex or sugammadex in combination with neostigmine 
Scientific Title of Study   Comparison of sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia : A randomised 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  ANELLIA DARI I KA MASSAR 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
795004
India 
Phone  9508216498  
Fax    
Email  anelliad@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Y Arunkumar Singh 
Designation  Associate Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
7950004
India 
Phone  9862282518  
Fax    
Email  yaks48@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Y Arunkumar Singh 
Designation  Associate Professor 
Affiliation  Regional Institute of Medical Sciences, Imphal, Manipur 
Address  Department of Anaesthesiology, Regional Institute of Medical Sciences Imphal

Imphal West
MANIPUR
7950004
India 
Phone  9862282518  
Fax    
Email  yaks48@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Imphal West Manipur 795004 India 
 
Primary Sponsor  
Name  Anellia Dari I Ka Massar 
Address  Regional Institute of Medical Sciences, Imphal, Imphal West Manipur 795004 India 
Type of Sponsor  Other [Post Graduate Trainee] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anellia Dari I Ka Massar  Regional Institute of Medical Sciences, Imphal, Imphal West, Manipur 795004 India  Elective surgery Operation theatre complex (OT 1-8) Department of Anaesthesiology, Regional Institue of Medical Sciences, Imphal Imphal West Manipur 795004 India
Imphal West
MANIPUR 
9508216498

anelliad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, 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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sugammadex   Group A will receive sugammadex at a dose of 2 mg/kg through intravenous route of administration as a single bolus dose at the end of the surgery for reversal of vecuronium-induced neuromuscular blockade when the two twitches to train of four stimulation appear in the TOF watch 
Comparator Agent  Sugammadex, neostigmine and glycopyrrolate combination   Group B will receive a combination of sugammadex 1 mg/kg with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg through intravenous route of administration as a single bolus dose at the end of the surgery for reversal of vecuronium-induced neuromuscular blockade when the two twitches to train of four stimulation appear in TOF watch 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients aged 18 to 60 years of either gender – male or female.
2. Patients with American Society of Anaesthesiologists (ASA) physical status Grade I to Grade II.
 
 
ExclusionCriteria 
Details  1. Patient’s refusal.
2. Patients with suspected difficult airway.
3. Patients with body mass index (BMI) more than 30 kg/m2.
4. Patients with known allergy to sugammadex, neostigmine and vecuronium.
5. Patients with pre-existent clinical conditions like chronic obstructive pulmonary disease, severe renal dysfunction, hepatic disease, cardiovascular disease, neurodegenerative disease and neuromuscular disease.
6. Pregnant or breastfeeding patients. 
 
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 
The time (in minutes) taken from the start of administration of the study drug (sugammadex or sugammadex combined with neostigmine) to the appearance of second twitch of train of four stimulation till recovery of normalised TOF ratio of 0.9 or more.  Outcome will be measured in a single time point, i.e. from the point of administration of study drug (baseline),till attainment of train of four ratio of 0.9 . 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters like Blood pressure, pulse rate, spo2, heart rate & also any adverse effects like bradycardia, tachycardia, hypotension, anaphylaxis, nausea
or vomiting.
 
Secondary outcomes will be measured from baseline that is at the time of administration of study drug. After that,it will be measured every 10 minutes thereafter till immediate postoperative period for upto 1 hour. 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   30/04/2025 
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="2"
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 - NO
Brief Summary  

        The use of neuromuscular blocking agents during induction of anaesthesia, facilitates intubation and improve surgical access by providing muscle relaxation and maintaining deep neuromuscular blockade until the end of the operation. Rapid reversal of neuromuscular blockade at the end of surgery is desirable to enhance patient safety and to avoid post operative complications like residual neuromuscular blockade.

Sugammadex is a novel agent without cholinergic side effects that specifically binds to steroidal neuromuscular blocking agents like vecuronium and rocuronium, reversing their effects and thus, rapidly restoring neuromuscular function.  The use of sugammadex along with neostigmine can enhance neuromuscular recovery, thereby allowing for a lower dosage of sugammadex to be administered. By reducing the dosage of sugammadex, it can lower the overall cost of sugammadex while its efficacy is preserved.

Hence, in this study we want to compare sugammadex and sugammadex combined with neostigmine for reversal of vecuronium induced neuromuscular blockade in patients undergoing general anaesthesia. After obtaining ethical clearance and written informed consent, a total number of 120 patients between 18-60 years of ASA physical status I and II undergoing elective surgery under general anaesthesia in the Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur will be randomly divided into two groups of 60 each. Group A patients will receive sugammadex at a dose of 2 mg/kg and Group B patients will receive a combination of sugammadex 1 mg/kg with neostigmine 50 mcg/kg and glycopyrrolate 10 mcg/kg for reversal of vecuronium induced neuromuscular blockade when two twitches to train of four stimulation appear. After administration of reversal agent, the time taken from the start of administration of the study drugs to the appearance of second twitch of train of four stimulation till recovery of its normalised ratio of 0.9 will be compared between the two groups. Additionally, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), oxygen saturation (SpO2) and heart rate (HR) will be recorded. All the findings and observations made during the entire study will be recorded in a proforma, tabulated in the EXCEL software and statistically analysed using SPSS software. Inference will be drawn to evaluate and compare the study drugs along with their clinical advantages and adverse effects.

 
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