| CTRI Number |
CTRI/2025/06/088927 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Prospective study to compare the post operative side effects of sugammadex and neostigmine as an agent of reversal for neuromuscular blockade in off pump coronary artery bypass grafting surgeries |
|
Scientific Title of Study
|
A Prospective Randomized Study to Compare the Post operative side effects of sugammadex vs neostigmine for reversal of vecuronium-induced neuromuscular blockade in patients undergoing CORONARY ARTERY BYPASS GRAFTING off pump |
| 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 Kiran Muthu Rajah |
| Designation |
SENIOR RESIDENT |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
87, 5th street, Dr Kothari nagar, Ramapuram, Chennai
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research, no.1, Mount Poonamallee road, Porur
Chennai
TAMIL NADU
600089
India |
| Phone |
9600001484 |
| Fax |
|
| Email |
kiranmuthurajah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ranjith B Karthekeyan |
| Designation |
Professor and Head of Department |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Cardiac anaesthesia, Sri Ramachandra Institute of Higher Education and Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9841136568 |
| Fax |
|
| Email |
ranjithkarthekeyan@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kiranmuthrajah |
| Address |
C-6,Sri Ramachandra Institute of Higher Education and Research,
Sri Ramachandra nagar, Porur, Chennai-600116 |
| Type of Sponsor |
Other [SELF] |
|
|
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 Kiran Muthu Rajah |
Sri Ramachandra Institute of Higher Education and Research |
6th floor Udayar block, Ramachandra Medical Centre, Ramachandra Nagar Porur
Chennai
TAMIL NADU |
9600001484
kiranmuthurajah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research INSTITUTIONAL RESEARCH ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I229||Subsequent ST elevation (STEMI) myocardial infarction of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sugammadex - reversal agent |
Modified gamma-cyclodextrin that binds to vecuronium causing rapid reversal from neuromuscular blockade. |
| Intervention |
To watch for time duration of reversal from neuromuscular blockade and to compare the post operative complications |
When compared to neostigmine, sugammadex requires lesser time of onset with reduced post operative complications. Total duration Post operative day 0 / 1 / 2 / 3. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. 18 years of age or older
2. Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy
|
|
| ExclusionCriteria |
| Details |
1. Age less than 18 years
2. Patient scheduled for emergency or redo surgeries
3. Patients with history of COPD / Pulmonary hypertension / hepatic or renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time from reversal administration at least 3 TOFR equal to or more than 0.9 |
3 minutes / 5 minutes / 10 minutes / 20 minutes / 30 minutes / 1 hour / 2 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of extubation from discontinuation of inhaled anaesthetic,
Need for reintubation,
Need for non invasive ventilation,
Duration of oxygen requirement post surgery,
Duration of ICU stay,
Bradycardia,
Bronchospasm,
Cardiac arrest. |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "124"
Final Enrollment numbers achieved (India)="124" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2025 |
| Date of Study Completion (India) |
01/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 prospective, randomized clinical study was designed to compare the postoperative side effects of sugammadex versus neostigmine in reversing vecuronium - induced neuromuscular blockade in patients undergoing off-pump coronary artery bypass grafting (CABG). Eligible patients were randomly allocated to receive either sugammadex or neostigmine at the end of surgery. The objectives of the study was time to onset of train of four from time of administration of reversal agents and evaluations of postoperative complications such as bradycardia, hypotension, nausea, vomiting, residual neuromuscular blockade, need for NIV support, need for reintubation ,cardiac arrest. The aim of the study was to determine safer and more effective reversal agent in context of CABG-off pump surgeries, where rapid and smooth recovery from neuromuscular blockade is critical. |