CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 260 enrolled
Drug / intervention
Sugammadex +1 moredrug
Likely dose
Sugammadex 2 mg/kgfrom 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/NCT02728726
NCT02728726Phase 4Completed
CompareCT.gov

Randomized Double---Blinded, Controlled Trial to Compare the Effectiveness of Sugammadex vs. Placebo to Prevent Residual Neuromuscular Block in the Post---Anesthesia Care Unit as Evaluated With a Non---Invasive Respiratory Volume Monitor

Mayo Clinic·interventional·Posted Apr 5, 2016·Updated Jul 14, 2022

In Brief

A Phase 4 clinical trial evaluating Sugammadex and Placebo for General Surgery. Completed, enrolled 260 participants across 2 sites.

Detailed Summary

The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneral Surgery
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC, University of Texas, Respiratory Motion, Inc.

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 5, 2016
Enrollment StartJun 1, 2016
Primary CompletionDec 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 10.2 years ago

Interventions

Sugammadexdrug

Sugammadex will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.

Placebodrug

Placebo will be administered intravenously at 2 mg/kg after routine reversal of anesthesia is performed and subject is extubated.