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CTRI Number  CTRI/2025/08/092380 [Registered on: 05/08/2025] Trial Registered Prospectively
Last Modified On: 04/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Sugammadex Alone to a Combination of Sugammadex and Neostigmine for Helping Overweight Patients Recover from Muscle Relaxants After Surgery 
Scientific Title of Study   Comparison of Sugammadex and Neostigmine combination versus Sugammadex for reversal of vecuronium induced neuromuscular blockade in overweight patients- 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 Prasanna Vadhanan 
Designation  HOD 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Room no 1 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post Karaikal PONDICHERRY 609609 India

Karaikal
PONDICHERRY
609609
India 
Phone  9486489690  
Fax    
Email  vadhanan.prasanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nithanthini B 
Designation  Junior Resident/Post Graduate 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Room no 2 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post Karaikal PONDICHERRY 609609 India

Karaikal
PONDICHERRY
609609
India 
Phone  9585011370  
Fax    
Email  bnithanthinikamacshi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nithanthini B 
Designation  Junior Resident/Post Graduate 
Affiliation  Vinayaka Missions Medical College and Hospital, Karaikal 
Address  Room no 2 Department of Anaesthesiology Vinayaka mission medical college and hospital Keezhakasakudy Medu Kottucherry Post Karaikal PONDICHERRY 609609 India


PONDICHERRY
609609
India 
Phone  9585011370  
Fax    
Email  bnithanthinikamacshi@gmail.com  
 
Source of Monetary or Material Support  
vinayaka missions medical college and hospital, karaikal, Puducherry-609609 
 
Primary Sponsor  
Name  Vinayaka Missions Medical College and Hospital  
Address  Keezhakasakudy Medu Kottucherry Puducherry 609609 
Type of Sponsor  Private 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 Nithanthini B  Vinayaka Missions Medical College and Hospital, Karaikal  Vinayaka Missions Medical College and Hospital, Keezhakasakudymedu,Kottuchery post, Karaikal, Puducherry-609609
Karaikal
PONDICHERRY 		 9585011370

bnithanthinikamacshi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  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  GROUP-S   patients receiving sugammadex alone at the end of surgery 
Comparator Agent  GROUP-SN   patients receiving half dose of sugammadex and neostigmine at the end of surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) BMI more than 25 kg per metre square
2) Undergoing elective surgery and requiring the use of muscle relaxants throughout the surgery.
3)ASA physical status 1 to 3
 
 
ExclusionCriteria 
Details  1) Presence of renal dysfunction defined as creatinine more than 1.2 mg per dl
2) Known hepatic disease
3) Obstructive sleep apnea
4) Allergic to general anaesthesia drugs
5) History of substance abuse.
-Altered mental status.
-Patients receiving medications known to interfere with neuromuscular transmission or having neuromuscular disease.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare effectiveness of sugammadex with neostigmine and sugammadex for reversal of vecuronium induced neuromuscular blockade in patients with BMI more than 25 kg per metre square by using 90 percentage TOF ratio  1 min, 5mins, 10mins, 15 mins,30 mins 
 
Secondary Outcome  
Outcome  TimePoints 
incidence of adverse events less in combined half dose of sugammadex & neostigmine & to find which is cost effective  within 24 hours post surgery 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   20/08/2025 
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)   Open to Recruitment 
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   This randomized controlled trial aims to compare the efficacy and safety of a half-dose sugammadex combined with neostigmine versus full-dose sugammadex alone for reversing vecuronium-induced deep neuromuscular blockade in patients with BMI > 25kg/m² undergoing elective surgeries under general anesthesia. The study addresses both clinical outcomes and economic considerations, given the high cost and potential adverse effects of sugammadex at full doses. The primary endpoint is the time to disappearance of fade in Double Burst Stimulation (DBS), with secondary endpoints including adverse effects, extubation time, cost-effectiveness, and hemodynamic changes. Ninety patients will be enrolled in a double-blinded, randomized design at a tertiary care hospital. This study hopes to establish a safer, faster, and more cost-effective reversal strategy in overweight and obese patients. 
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