ActivePhase 4ACTRN12623000394640

Sugammadex, neostigmine and postoperative pulmonary complications (SNaPP): a randomised controlled trial

The SNaPP Study: A multi-centre, patient- and observer-blinded randomised controlled trial of sugammadex or neostigmine to reverse neuromuscular blockade in adult patients having abdominal and thoracic surgery under general anaesthesia

Sponsor

University of Melbourne

Enrollment

3,500 participants

Start Date

Jul 20, 2023

Study Type

Interventional

Conditions

Pulmonary aspiration Pneumonia

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 conducting a large multi-centre randomised controlled trial to investigate whether sugammadex is associated with fewer postoperative lung complications than neostigmine.

Eligibility

Sex: Both males and femalesMin Age: 40 Yearss

Inclusion Criteria4

Plan for elective or expedited intraabdominal, retroperitoneal, pelvic and non-cardiac intrathoracic surgery
Plan for relaxant general anaesthesia with an endotracheal tube
Surgery expected to last greater than or equal to 2 hours
Expected hospital stay of greater than or equal to 1 postoperative night

Exclusion Criteria8

Unable to provide written informed consent (e.g., language barrier, intellectual disability, cognitive deficit, urgent surgery)
Plan for skin incision and/or vascular access at or below the inguinal ligament without an abdominal or thoracic skin incision
Plan for intraoperative administration of neuromuscular blocking drug other than rocuronium and vecuronium
Plan to reverse neuromuscular blockade during surgery
Plan to allow spontaneous complete recovery from neuromuscular blockade during surgery
Contraindication to sugammadex or neostigmine
Plan for elective postoperative invasive ventilation
Previously randomised to the trial

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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, reversal drug name and dose will be recorded in the hospital medical record. Adherance to the intervention will be monitored via audit of the hospital medical record.