CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
Sugammadex +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02666014
NCT02666014Phase 3Completed

Comparison of Sugammadex Versus Neostigmine in Women at High Risk of Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery: A Randomized Controlled Trial

KK Women's and Children's Hospital·interventional·Posted Jan 28, 2016·Updated Jun 28, 2018

In Brief

A Phase 3 clinical trial evaluating Sugammadex and Neostigmine for Postoperative Nausea and Vomiting. Completed, enrolled 184 participants across 1 site.

Detailed Summary

The laparoscopic technique is commonly employed for abdominal gynaecological surgery in women. Postoperative nausea and vomiting (PONV) may occur in 30% of women undergoing gynaecological surgery. In patients with multiple risk factors for nausea and vomiting, the incidence is up to 80%. PONV has a significant negative effect on patient satisfaction after anesthesia and is one of the most common causes for unexpected hospital admissions in day-surgery. Sugammadex and Neostigmine are both drugs that are used to reverse the effect of muscle relaxation producing drugs that are commonly used during surgery. Neostigmine has been the drug of common use for this purpose, but PONV is reported with its usage. With this research we intend to determine whether the trial drug Sugammadex would reduce the incidence of PONV in high-risk women after undergoing laparoscopic gynaecological surgery when compared to Neostigmine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSingapore

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 28, 2016
Enrollment StartJun 1, 2015
Primary CompletionDec 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 10.4 years ago

Interventions

Sugammadexdrug

Reversal of neuromuscular blockade

Neostigminedrug

Reversal of neuromuscular blockade