None listed
Conditions
Brief summary
During general anaesthesia muscle relaxant drugs are administered to make airway management and surgery easier. Muscle relaxants are usually reversed with neostigmine at the end of the operation. A newer drug, sugammadex, reverses muscle relaxants more rapidly than neostigmine, but is not clear whether sugammadex results in fewer postoperative complications than neostigmine. We are planning a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine. The current study is a pilot study that will determine if the larger trial is feasible. We will measure feasibility outcomes (e.g. recruitment rates) and pilot the main trial outcomes (e.g. postoperative pulmonary complications)
Interventions
Sugammadex as a single intravenous dose at the end of surgery with dose personalised by quantitative neuromuscular monitoring. Quantitative neuromuscular monitoring is recommended by the Australian and New Zealand College of Anaesthetists. It is applied at induction of anaesthesia and is removed after reversal of neuromuscular blockade at the end of surgery. Quantitative neuromuscular monitoring results will be recorded in the case report form. Administration of neostigmine instead of sugammadex
Sugammadex as a single intravenous dose at the end of surgery with dose personalised by quantitative neuromuscular monitoring. Quantitative neuromuscular monitoring is recommended by the Australian and New Zealand College of Anaesthetists. It is applied at induction of anaesthesia and is removed after reversal of neuromuscular blockade at the end of surgery. Quantitative neuromuscular monitoring results will be recorded in the case report form. Administration of neostigmine instead of sugammadex will be at the discretion of the anaesthetist based on patient safety considerations.
Sponsors
Melbourne Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Plan for elective or expedited intraabdominal, retroperitoneal, pelvic and non-cardiac intrathoracic surgery b) Plan for relaxant general anaesthesia with an endotracheal tube c) Surgery expected to last greater than or equal to 2 hours d) Expected hospital stay of greater than or equal to 1 postoperative night
Exclusion criteria
a) Unable to provide written informed consent (e.g. language barrier, intellectual disability, cognitive deficit, urgent surgery) b) Plan for skin incision and/or vascular access at or below the inguinal ligament without an abdominal or thoracic skin incision c) Plan for intraoperative administration of neuromuscular blocking drug other than rocuronium and vecuronium d) Plan to reverse neuromuscular blockade during surgery e) Plan to allow spontaneous complete recovery from neuromuscular blockade during surgery f) Contraindication to sugammadex or neostigmine g) Plan for elective postoperative invasive ventilation h) Previously randomised to the trial
Outcome results
None listed