CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 75 enrolled
Drug / intervention
sugammadex 2mg/kg +6 moredrug
Likely dose
sugammadex 2mg/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/NCT01962298
NCT01962298Phase 3Completed

Sugammadex and the Diaphragm: Recovery of Diaphragmatic Function and Neuromuscular Blockade. A Double-blind Randomized Controlled Trial

University Hospital, Antwerp·interventional·Posted Oct 14, 2013·Updated Oct 24, 2018

In Brief

A Phase 3 clinical trial evaluating sugammadex 2mg/kg, neostigmine, and 5 other interventions for Diaphragmatic Dysfunction and 2 related conditions. Completed, enrolled 75 participants across 1 site.

Detailed Summary

The effect of neuromuscular blocking agents (NMBA, e.g. rocuronium) on respiratory muscle activity is well known. However, since the availability of sugammadex, to our knowledge, no study has been conducted to evaluate the effect of this novel product on these muscles. Our hypothesis is that by applying a different strategy in the use of neuromuscular blocking agents and their reversal agents we might see a different activity of the respiratory muscles.

Study Details

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

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 14, 2013
Enrollment StartOct 1, 2013
Primary CompletionDec 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 12.7 years ago

Interventions

sugammadex 2mg/kgdrug

neostigminedrug

sugammadex 4mg/kgdrug

placebodrug

Single rocuronium dosedrug

Repeated rocuronium dosedrug

Continuous rocuronium infusiondrug