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
Overview
- Phase
- Phase 2/3
- Status
- Completed
- Sponsor
- Kiranmuthrajah
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Time from reversal administration at least 3 TOFR equal to or more than 0.9
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •18 years of age or older
- •Scheduled for elective cardiac surgery with general anesthesia, invasive mechanical ventilation, complete median sternotomy.
Exclusion Criteria
- •Age less than 18 years
- •Patient scheduled for emergency or redo surgeries
- •Patients with history of COPD / Pulmonary hypertension / hepatic or renal dysfunction.
Outcomes
Primary Outcomes
Time from reversal administration at least 3 TOFR equal to or more than 0.9
Time Frame: 3 minutes / 5 minutes / 10 minutes / 20 minutes / 30 minutes / 1 hour / 2 hour
Secondary Outcomes
- Time of extubation from discontinuation of inhaled anaesthetic,(Need for reintubation,)
Investigators
Dr Kiran Muthu Rajah
Sri Ramachandra Institute of Higher Education and Research