Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

Phase 3 Completed 52 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.

Timeline

Start: 2006-12-07
Primary completion: 2007-03-02
Completion: 2007-03-02

Outcome

Met primary endpoint

paper The estimated difference in recovery time between groups was 9 s (95% confidence interval -6 to 20 s), entirely within the predefined equivalence interval. PMID 19512873 ↗

Publications

Results Rex C, Wagner S, Spies C, Scholz J, Rietbergen H, Heeringa M, Wulf H. Reversal of neuromuscular blockade by sugammadex after continuous infusion of rocuronium in patients randomized to sevoflurane or propofol maintenance anesthesia. Anesthesiology. 2009 Jul;111(1):30-5. doi: 10.1097/ALN.0b013e3181a51cb0.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Propofol	Small molecule	—	Intravenous
Subject	Rocuronium	Other / unclassified	7 ug/kg	—
Subject	Sevoflurane	Other / unclassified	—	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	—

Indications

No indication recorded.