The effect of two different drugs on post-operative well-being, nausea and vomiting in patients undergoing laparoscopic gynaecological surgery

Neostigmine and glycopyrrolate versus sugammadex in post-operative nausea and vomiting (PONV) following reversal of neuromuscular block in patients undergoing laparoscopic gynaecological surgery: a randomised controlled trial (RCT).

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000789965

Acronym

WINGS

Enrollment

307

Registered

2011-07-28

Start date

2011-10-20

Completion date

2016-10-27

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

To compare patient outcome, the primary endpoint being the incidence of post-operative nausea and vomiting (PONV), associated with the use of either neostigmine and glycopyrrolate or sugammadex for the routine reversal of neuromuscular block following laparoscopic gynaecological surgery. Secondary outcomes to be assessed include readiness to discharge, return of normal bowel function, patient recovery and well-being.

Interventions

Administration of an intravenous bolus of sugammadex 2mg/kg actual body weight, following surgery and prior to emergence from anaesthesia, in patients where rocuronium has been used, and where at least two twitches of a 'train-of-four' nerve stimulation test has been demonstrated.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

ASA I – III physical status; Elective or non-elective laparoscopic gynaecological surgery; General anaesthesia with intravenous induction of anaesthesia and neuromuscular block with rocuronium; Ability to communicate in English.

Exclusion criteria

Anaphylaxis or hypersensitivity to any of the study drugs; Anaesthetist preference to avoid a long acting muscle relaxant (for example, known or anticipated difficult airway); Preoperative or perioperative conversion to open abdominal surgery; Preoperative nausea and/or vomiting within 48 hours of surgery; Neuromuscular disease; Hepatic or renal dysfunction; Personal or family history of malignant hyperpyrexia; Long QT syndrome; Pregnancy or breastfeeding; Unsuitable for follow-up by phone at 24 hours (if day stay procedure).

Outcome results