Use of Sugammadex Administered at 5 Minutes After Administration of 1.2 mg/kg Esmeron® (19.4.205)(P05942)

Phase 2 Completed 45 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the optimal dose of sugammadex when this compound is administered during deep neuromuscular block. Sugammadex is administered shortly (5 minutes) after administration of a high dose (1.2 mg/kg) of the neuromuscular blocking agent rocuronium . Under these circumstance the neuromuscular block is deep. The safety and pharmacokinetics of sugammadex are also studied.

Timeline

Start: 2003-11-07
Primary completion: 2004-07-14
Completion: 2004-07-14

Publications

Results de Boer HD, Driessen JJ, Marcus MA, Kerkkamp H, Heeringa M, Klimek M. Reversal of rocuronium-induced (1.2 mg/kg) profound neuromuscular block by sugammadex: a multicenter, dose-finding and safety study. Anesthesiology. 2007 Aug;107(2):239-44. doi: 10.1097/01.anes.0000270722.95764.37.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	8 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	12 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	16 mg/kg	Intravenous

Indications

No indication recorded.