| 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
|
|
|
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
|
|
|
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. |