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CTRI Number  CTRI/2025/07/091077 [Registered on: 17/07/2025] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   participants of group 1mg per kg sugammadex combined with neostigmine 50micrograms per kg were compared with that of 2mg per kg sugammadex group for the main out come of reversal of neuromuscular block in abdominal surgries under general anaesthesia  
Scientific Title of Study   To compare safety and efficacy of 1mg/kg sugammadex combining with neostigmine 50µg/kg versus 2mg/kg sugammadex for reversal of vecuronium induced shallow neromuscular block in abdominal 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  Dr Yathish S K 
Designation  Assistant professor 
Affiliation  Bangalore medical college and research institute Bangalore 
Address  Department of anaesthesia Bangalore medical college

Bangalore
KARNATAKA
560096
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yathish S K 
Designation  Assistant professor 
Affiliation  Bangalore medical college and research institute Bangalore 
Address  Department of anaesthesia Bangalore medical college
bangalore medical college
Bangalore
KARNATAKA
560002
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Yathish S K 
Designation  Assistant professor 
Affiliation  Bangalore medical college and research institute Bangalore 
Address  Department of anaesthesia Bangalore medical college
bangalore medical college
Bangalore
KARNATAKA
560002
India 
Phone  7338595885  
Fax    
Email  skyathish86@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Medical college and Research institue bangalore 560002 karnataka India. 
 
Primary Sponsor  
Name  Bangalore medical college and research institute 
Address  bangalore medical college Fort Krishna Rajendra road Kalasipalya bengalore karnataka India 560002 
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 Yathish S K  Bangalore Medical College and Research institute  department of anaesthesia BMCRI bangalore 560002
Bangalore
KARNATAKA 
7338595885

skyathish86@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee of Bangalore Medical College and Research Institute   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K829||Disease of gallbladder, unspecified, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  suggamadex 1mg per kg plus neostigmine 50microgram per kg  to compare the time required for reversal of adequate neuromuscular blockade with suggamadex 1mg per kg with neostigmine 50 microgram/kg observed for until 1 hour after surgery is completed  
Intervention  suggamadex 2mg/kg  to compare the time required for reveersal of adequate neuromuscular blockade with suggamadex 2mg/kg observed until 1 hour post surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age 18 to 65yr
2. Patient willing to give informed consent.
3. ASA 1-2
4. Patients undergoing elective abdominal surgery under general aneasthesia

 
 
ExclusionCriteria 
Details  1 Age more than 65years
2 ASA 3
3 patients undergoing emergency surgery
4 patients having allergy to drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare time required for adeqaute reversal of neuromuscular blockade .
recovery of the patient observed every 20 seconds for 1 hour post surgery 
To compare time required for adeqaute reversal of neuromuscular blockade .
recovery of the patient observed every 20 seconds until 1 hour post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
to know the side effects  observed until 1 hour post surgery  
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   28/07/2025 
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="3"
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  

Elective abdominal surgeries are planned procedures, and can include procedures like appendectomy, cholecystectomy, hernia repair, and colorectal surgery, often performed laparoscopically for better recovery.

Laparoscopic surgery is now widely established. Benefits include reduced postoperative pain, improved cosmetic results and patient satisfaction, and reduced hospital stays. The range of surgical techniques is increasing in complexity and now includes cholecystectomy, adrenalectomy, nephrectomy, fundoplication, hernia repair, bowel resection and gynaeco logical procedures,where  general anaesthesia is preferred.

 

Sugammadex is a new reversal agent that works differently than cholinesterase inhibitor neostigmine .It  binds with high affinity to vecuronium and rocuronium in blood decreasing its plasma concentration and creating a gradient between the plasma and the neuromuscular junction, This process results in removing the non depolarizing agent from there  receptors as it follows the concentration gradient towards the blood.

 

 A dose of 4mg/kg and 2 mg/kg has been established for reversal of deep and shallow neuromuscular block induced by rocuronium and vecuronium.[4]However   the high cost of this drug is prohibitive and is a significant limitation for its routine use in many institutions, especially when higher doses are required.Few studies have suggested that  a  dose of 0.22 mcg/kg Sugammadex and 34mcg/kg neostigmine accelerates recovery from TOF ratio of 0.5 to a ratio of at least 0.9 in an average of 2 min .

We hypothesize that the combination of neostigmine with half dose sugammadex (1mg/kg) would be non inferior to 2mg/kg recommended dose in reversing vecuronium induced shallow NMB.Given the high cost of Sugammadex this multimodal approach would be an effective cost reducing method ,while preserving the advantage of this novel agent .

 
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