CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 18 enrolled
Drug / intervention
Sugammadex +2 moredrug
Likely dose
Sugammadex 2mg/kgfrom record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02403063
NCT02403063Phase 4Completed

Electromyographic Activity of the Diaphragm and of the Rectus Abdominis and Intercostal Muscles During Neostigmine, Sugammadex, or Neostigmine-sugammadex Enhanced Recovery After Neuromuscular Blockade With Rocuronium. A Randomised Controlled Study in Healthy Volunteers

Onze Lieve Vrouw Hospital·interventional·Posted Mar 31, 2015·Updated Nov 20, 2015

In Brief

A Phase 4 clinical trial evaluating Sugammadex, Neostigmine, and 1 other intervention for Respiratory Muscles and Electromyography. Completed, enrolled 18 participants across 1 site.

Detailed Summary

It was recently shown that neostigmine reversal was associated with increased atelectasis and that high-dose neostigmine was associated with longer postoperative length of stay and with an increased incidence of pulmonary edema and reintubation. These study results were consistent with findings from a previous epidemiological study which revealed an absence of beneficial effects of neostigmine on postoperative oxygenation and reintubation. In our previous study, the effects of neostigmine / glycopyrrolate and sugammadex on the electromyographic activity of the diaphragm showed beneficial effects for sugammadex. This could be explained by a possible effect on neuromuscular transmission at the muscle level, but can also be explained by a neostigmine-induced decrease in total nerve activity. In a study in cats, neostigmine has been shown to reduce efferent phrenic nerve activity. The investigators aim to show a difference in phrenic nerve activity between neostigmine and sugammadex, administered alone or in combination, in healthy male volunteers.

Study Details

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

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 31, 2015
Enrollment StartSep 1, 2015
Primary CompletionOct 1, 2015
Study CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 11.3 years ago

Interventions

Sugammadexdrug

Administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium

Neostigminedrug

Administration of neostigmine 50µg/kg for enhanced recovery after neuromuscular blockade with rocuronium

Neostigmine-sugammadexdrug

Administration of neostigmine 50µg/kg followed 3 minutes later by administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium