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CTRI Number  CTRI/2024/03/063566 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 29/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Use of Newer Nueromuscular reversal agent - Sugammadex vs the conventional drug Neostigmine to enhance recovery after Cardiac surgery. 
Scientific Title of Study   ENHANCED RECOVERY AFTER CARDIAC SURGERY – USE OF SUGAMMADEX VS NEOSTIGMINE: A RANDOMIZED CONTROLLED TRIAL  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  Room no. 305, Department of Cardiovascular surgery and Cardiac Anesthesia, CVTC building, Seth GS Medical College and KEM hospital, Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  Room no. 305, Department of Cardiovascular surgery and cardiac anesthesia, CVTC building - ground floor, Seth GS Medical College and KEM hospital, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sanjeeta Umbarkar 
Designation  Professor (Addl) and Head of Department Cardiac Anaesthesia 
Affiliation  Seth GS medical college and KEM hospital, MUMBAI 
Address  Room no. 305, Department of Cardiovascular surgery and cardiac anesthesia, CVTC building - ground floor, Seth GS Medical College and KEM hospital, Parel, Mumbai


MAHARASHTRA
400012
India 
Phone  8879875834  
Fax    
Email  sanjeeta69@yahoo.com  
 
Source of Monetary or Material Support  
Research grant from Institutional Research Society, Seth GS Medical College and KEM hospital, Parel, Mumbai  
 
Primary Sponsor  
Name  Institutional Research Society 
Address  Institutional Research Society, Seth GS Medical College and KEM hospital, Mumbai 
Type of Sponsor  Research institution 
 
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 Sanjeeta Umbarkar  Seth GS Medical College and KEM hospital, Parel, Mumbai  Cardiovascular Thoracic Operation Theatre, CVTC Building, 2nd floor Seth GS Medical College and KEM hospital, Parel, Mumbai
Mumbai
MAHARASHTRA 
9323273435

sanjeeta69@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) - II, Relating to Biomedical and health research (BHR). Seth GS Medical College and KEM hospital, Mumbai, Maharashtra, India. Established - 14th November 2008  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Inj. Neostigmine 50 mcg/kg once, intravenously  Neuromuscular blockage reversal after surgery using 50 mcg/kg once, intravenously after return of TOF count 2 twitches after surgery in the post operative recovery area. 
Intervention  Inj. Sugammadex 2 mg/kg Intravenously, administered once.  Neuromuscular blockage reversal after surgery using 2 mg/kg drug once, intravenously after return of TOF count 2 twitches after surgery in the post operative recovery area. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  American Society of Anaesthesiologist (ASA) physical status
II - III undergoing elective open heart surgeries under general anaesthesia, and requiring
rocuronium-induced neuromuscular blockade will be included in the study. This includes patients undergoing -
1. Aortic valve replacement
2. Mitral valve replacement
3. Atrial septal defect closure
4. Ventricular septal defect closure 
 
ExclusionCriteria 
Details  Aortic cross clamp time more than 100 minutes
Difficulty in weaning from cardiopulmonary bypass despite adequate inotropic support
Patients with preexisting DM, thyroid disorders and neuromuscular disorders
Postoperative hemodynamic instability making patient not suitable for weaning from ventilator 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time to extubation in post anesthesia care unit, which is the time in minutes from procedure
stop to the time of extubation 
Upto 6 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Respiratory parameters after surgery
Delirium in the postoperative care unit
Time to return of bowel sounds after surgery
Time to first ambulation
Time to discharge from ICU 
Upto 12 hours after surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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 3 
Date of First Enrollment (India)   18/03/2024 
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="4"
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  

Cardiac surgical patients account for a vast majority of the high-risk perioperative population. Enhanced Recovery After Surgery (ERAS) are multidisciplinary perioperative pathways designed to reduce surgical insult, prevent healthcare-associated complications, and hasten patient recovery through the bundled application of evidence-based measures. With the advancement of newer drugs and improved techniques in cardiac anaesthesia and surgery, the application of ERAS pathways in cardiac surgery is possible but clear evidence-based protocols for the use of ERAS in cardiac surgical patients are still lacking.

Neostigmine, an acetylcholinesterase inhibitor, has classically been the neuromuscular blockade reversal agent in all patient groups. Sugammadex is a gamma-cyclodextrin drug and is FDA approved for neuromuscular paralysis reversal after surgery. It rapidly reverses neuromuscular block by encapsulating the nondepolarizing aminosteroid paralysing agents like rocuronium and vecuronium. We aim to conduct a single-center, randomized, double-arm prospective study involving adult patients undergoing open heart surgeries to evaluate the use of sugammadex in applying ERAS protocol in cardiac surgery by comparing the time to extubation and other postoperative recovery parameters upon using Sugammadex vs the standard reversal agent, Neostigmine.

After Institutional Ethics Committee permission, we propose to conduct a randomized controlled study over 4 months in 80 patients, aged 18-65 years American Society of Anaesthesiologist (ASA) physical status II - III undergoing elective open heart surgeries under general anaesthesia, and requiring rocuronium-induced neuromuscular blockade. Following ERAS protocols for cardiac surgery, the patients will be undergoing cardiac surgery and shifted intubated to ICU where they will be administered either Neostigmine (Group N) or Sugammadex (Group S). Thereafter, the postoperative recovery parameters will be assessed.

The data will be collected, compiled, and analyzed using SPSS version 25. The qualitative variables will be expressed in terms of percentages. The quantitative variables will be both categorized and expressed in terms of percentages or in terms of mean and standard deviations. The difference between the two groups will be analyzed using a student t test. The difference between the two proportions will be analyzed using chi-square or Fisher exact test. All analysis will be 2 tailed, and the significance level will be set at 0.05.

 
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