Trial overview

Trial Title	Sugammadex for preventIoN of pOst-operative pulmoNary complIcAtions - SINFONIA
Primary objective	To determine whether sugammadex is superior to neostigmine after elective or emergency major abdominal or non-cardiac thoracic surgery in terms of days alive and out of hospital at 30 days (DAH30)
Trial Design	Randomised clinical trial with embedded observational study
Trial Participants	Patients aged >50 year old undergoing elective or emergency major abdominal or non-cardiac thoracic surgery planned to receive neuromuscular blockade with rocuronium or vecuronium with reversal at the end of surgery
Exclusion Criteria	1. Known allergy to sugammadex, neostigmine or glycopyrrolate 2. Lack of written informed consent for trial participation 3. Planned invasive mechanical ventilation before or after surgery 4. Previous participation in SINFONIA trial 5. Clinician refusal
Sample Size	2500
Treatment Duration	Single bolus dose, repeated once if deemed necessary by the treating clinician
Follow-up Duration	180 days
Outcome Measures	1. Days alive out of hospital at 30 days (DAH30) 2. Post-operative Pulmonary Complications (PPCs) within seven days after surgery 3. Mortality at 30 days and 180 days after surgery 4. Health-related quality of life at 7, 30 and 180 days (EQ-5D-5L) 5. Allergic reaction within 24 hours after administration of IMP

Please find attached below v3.0 of the Sinfonia Trial protocol

Trial Manager: Kirsten Harris

Trial Coordinator: Hannah McNeil

Data Entry Clerk: David Lomax

Tel: +44 (0)24 7615 0963

Email: sinfonia@warwick.ac.uk

Address:
Sinfonia Trial Team,
Warwick Clinical Trials Unit,
Warwick Medical School,
University of Warwick,
Gibbet Hill Campus,
Coventry,
CV4 7AL