A Bridging Trial Comparing Sugammadex (Org 25969) at 1-2 Post-Tetanic Count (PTC) in Caucasian Participants. Part B (P05974)

Phase 2 Completed 102 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants

Timeline

Start: 2005-10-04
Primary completion: 2006-09-15
Completion: 2006-09-15

Publications

Duvaldestin P, Kuizenga K, Saldien V, Claudius C, Servin F, Klein J, Debaene B, Heeringa M. A randomized, dose-response study of sugammadex given for the reversal of deep rocuronium- or vecuronium-induced neuromuscular blockade under sevoflurane anesthesia. Anesth Analg. 2010 Jan 1;110(1):74-82. doi: 10.1213/ANE.0b013e3181c3be3c. Epub 2009 Nov 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sugammadex	Other / unclassified	0.5 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	1 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	8 mg/kg	Intravenous

Indications

No indication recorded.