Elective or emergency major abdominal or non-cardiac thoracic surgery Surgery
Conditions
Interventions
Current interventions as of 04/04/2025:
This randomised trial will compare the effectiveness of two drugs for the reversal of neuromuscular blocking agents at the end of anaesthesia to prevent postope
Sponsors
Belfast Health and Social Care Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients presenting for elective or emergency major abdominal or non-cardiac thoracic surgery 2. Age =50 years 3. Planned use of rocuronium or vecuronium for neuromuscular blockade 4. Planned reversal of neuromuscular blockade at the end of surgery
Exclusion criteria
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 (with reason)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Days alive and out of hospital at 30 days following surgery (DAH30), captured via questions on case report form (CRF): ‘Patient still alive at 30 days’ – ‘Since their initial discharge after surgery, has the patient been readmitted to hospital’, if yes space provided to add dates, captured on the day 30 post Op form. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Postoperative Pulmonary Complications (PPCs) within 7 days after surgery, captured via questions on CRF: ‘Post-operative pulmonary complications’ – list of these with Yes/No captured on the day 7 post Op form 2. Mortality at 30 and 180 days after surgery, captured via questions on CRFs: 2.1. Patient still alive at 30 days – captured on day 30 post op form 2.2. Patient still alive at 180 days – captured on day 180 post op form 2.3. If no date of death – captured on day 30/180 post op form 3. Quality of recovery on the first post-operative day, measured using QoR-15 on day 1 post op form 4. Health-related quality of life at 7, 30 and 180 days measured using EQ-5D-5L at baseline, day 7 post op, day 30 post op and day 180 post op 5. Allergic reaction within 24 hours after administration of IMP (clinician defined), captured via question on CRF - In the 24 hours following administration of the IMP, has the patient had an allergic reaction? – collected on day 1 post-op form 6. Health resource use during the 180 days after surgery, captured via questions on CRFs, Details of hospital stay (including critical care admissions and re-admissions) Details of community and outpatient visits, captured on both day 30 and day 180 post-op forms 7. Rate of allergic sensitisation to sugammadex (for the allergic sensitisation sub-study only), captured via a CRF – there will be a Final adjudication panel with overall outcome of allergy testing – captured on the Sub-Study Form with the following options: 7.1. Evidence of clinically relevant sensitisation 7.2. No evidence of clinically relevant sensitisation (all test modalities negative OR a single positive test followed by a negative drug provocation test) 7.3. Low certainty of clinically relevant sensitisation (equivocal results) 7.4. Unable to confirm whether clinically relevant sensitisation present (testing not completed) | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactKirsten Harris
Outcome results
None listed