CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 46 enrolled
Drug / intervention
Sugammadex +2 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/NCT02845375
NCT02845375Phase 4Completed

Effect of Neuromuscular Blockade and Reversal by Sugammadex Versus Neostigmine on Breathing When Hypoxic or Hypercapnic in Volunteers

Leiden University Medical Center·interventional·Posted Jul 27, 2016·Updated Feb 19, 2020

In Brief

A Phase 4 clinical trial evaluating Sugammadex, Neostigmine, and 1 other intervention for Respiratory Insufficiency. Completed, enrolled 46 participants across 1 site.

Detailed Summary

In this study the investigators will assess (i) the effect of partial neuromuscular blockade (NMB; TOF ratio 0.8 and 0.6) induced by low-dose rocuronium on the ventilatory response to isocapnic hypoxia and (ii) the effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers. Additionally the investigators will assess the effect of partial NMB (TOF ratio 0.6) induced by low-dose rocuronium on the ventilatory response to hypercapnia and effect over time (from TOF 0.6 to TOF 1.0) of the reversal by sugammadex, neostigmine or placebo in healthy volunteers.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNetherlands
Collaborators--

Timeline

Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 27, 2016
Enrollment StartSep 1, 2016
Primary CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 9.9 years ago

Interventions

Sugammadexdrug

Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

Neostigminedrug

Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.

Placebodrug

Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.