Sugammadex, neostigmine and postoperative pulmonary complications in noncardiac surgery

Sugammadex, neostigmine and postoperative pulmonary complications in noncardiac surgery

 

The SNaPP Study is a large (n=3,500) four year, multicentre, double-blind, randomised clinical trial examining the effect of reversal of neuromuscular blockade on postoperative outcomes.

Adult patients having abdominal or thoracic surgery under relaxant general anaesthesia with an endotracheal tube will be randomised to sugammadex or neostigmine for reversal of neuromuscular blockade. The primary outcome is a composite of death or postoperative pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).

The team from the University of Melbourne is led by Professor Kate Leslie AO FAHMS. The trial is funded by a $2.9 million grant from the Medical Research Future Fund. Please email Sofia Sidiropoulos if you are interested in being involved or would like further information about the SNaPP Study.
 

Principal investigator

Professor Kate Leslie AO FAHMS (Royal Melbourne Hospital and University of Melbourne)

Expression of Interest

Please email Sofia Sidiropoulos if you are interested in being involved or would like any further information about the SNaPP Study.

Start-up meeting

The start-up meeting was held at the ANZCA CTN workshop in August 2023.
 

Trial summary

Study summary
The SNaPP Study is a multicentre, double-blind, randomised clinical trial examining the effect of reversal of neuromuscular blockade on postoperative outcomes. Adult patients having abdominal or thoracic surgery under general anaesthesia will be randomised to sugammadex or neostigmine for reversal of neuromuscular blockade. The primary outcome is a composite of death or postoperative pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).

Eligibility
Patients aged 40 years and over, scheduled for abdominal or thoracic surgery under relaxant general anaesthesia with an endotracheal tube, with expected operative time of ≥2 hours and hospital stay ≥1 postoperative night.

Study intervention
Sugammadex or neostigmine for reversal of neuromuscular blockade

Primary endpoint
A composite of death or postoperative pulmonary complications up to hospital discharge (or postoperative day 7 if still in hospital).

Secondary endpoints
Secondary endpoints include components of the composite primary outcome, postoperative nausea and vomiting, unplanned ICU/HDU admission, days alive and at home, and change in health-related quality of life. Exploratory endpoints include duration of post anaesthesia care unit stay, airway instrumentation in the post anaesthesia care unit, change in quality of recovery score, change in frailty and severity of postoperative pulmonary complications. A health economic analysis is also planned.

Safety endpoints

A comprehensive set of events will be recorded as trial safety endpoints.

Sample size
3,500 patients

Study duration
Four years

Funding

Medical Research Future Fund grant $2,948,208.65 (2023-2027)

The Australian and New Zealand College of Anaesthetists Foundation (2020) (CTN pilot study) $10000

Operations Committee

Professor Kate Leslie AO FAHMS
Professor David Story
A/Professor Jai Darvall
Professor Philip Peyton
Ms Sofia Sidiropoulos

Collaborators

The University of Melbourne (Administering institution)
Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA CTN)
 

Progress


The SNaPP Study commenced recruitment in July 2023 at Royal Melbourne Hospital. To date 875,  patients have been enrolled at 30 participating sites. Many sites are navigating the ethics and governance processes and we look forward to them recruiting soon. 

 

Publications

Leslie K, Chan MTV, Darvall JN, et al. Sugammadex, neostigmine and postoperative pulmonary complications: an international randomised feasibility and pilot trial. Pilot Feasibility Stud 2021; 7: 200.

Media Release

Presentations

Presented at the annual CTN workshops in 2020 and 2021 by Professor Kate Leslie (AO).

Endoresements

Australian and New Zealand College of Anaesthetists Clinical Trials Network (2020)

Trial registration

ANZCTR identifier: 12623000394640

Participating hospitals

Participating hospitals
Alfred Health
Auckland City Hospital
Austin Health
Counties Manukau
Flinders Medical Centre
Logan Hospital
Mackay Base Hospital
Monash Medical Centre, Clayton
Monash Moorabbin 
Northern Health
Peninsula Health
Peter MacCallum Cancer Centre
Princess Alexandra Hospital
Queen Elizabeth II Jubilee Hospital
Redcliffe Hospital
Royal Adelaide Hospital
Royal Brisbane and Women's Hospital
Royal Melbourne Hospital
Royal North Shore Hospital
Royal Prince Alfred Hospital
St Vincent's Hospital Melbourne
St Vincent's Hospital Sydney
University Hospital Geelong
Waitemata District Health Board, North Shore Hospital
Westmead Hospital
Western Health, Footscray
Western Health, Sunshine
International sites
Prince of Wales Hospital, Hong Kong
Tuen Mun Hospital

Last updated 14:38 13.11.2024