drugset / Trial / NCT02845375

Effect of Neuromuscular Blockade and Reversal on Breathing

NCT02845375 ↗

Phase 4 Completed 46 enrolled Leiden University Medical Center
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2016-09-01
Primary completion
2018-09-01
Completion
2018-09-01

Outcome

Missed primary endpoint

registry analysis (superiority test); PLACEBO vs NEOSTIGMINE vs SUGAMMADEX; p = 0.299; ANCOVA NCT02845375 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Neostigmine Other / unclassified — Intravenous
Subject Sugammadex Other / unclassified — Intravenous

Indications