A Bridging Trial Comparing Sugammadex (Org 25969) at Reappearance of T2 in Japanese and Caucasian Participants. Part B: Caucasian Participants (P05971)

Phase 2 Completed 100 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupSingle-blindTreatment

Summary

The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) during sevoflurane anesthesia for Caucasian participants.

Timeline

Start: 2005-09-20
Primary completion: 2006-08-31
Completion: 2006-08-31

Outcome

Met primary endpoint

paper A statistically significant dose-response relationship was demonstrated for mean recovery times of T₄/T₁ ratio to 0.9 with increasing sugammadex dose with both NMBAs: PMID 20876699 ↗

Publications

Results Puhringer FK, Gordon M, Demeyer I, Sparr HJ, Ingimarsson J, Klarin B, van Duijnhoven W, Heeringa M. Sugammadex rapidly reverses moderate rocuronium- or vecuronium-induced neuromuscular block during sevoflurane anaesthesia: a dose-response relationship. Br J Anaesth. 2010 Nov;105(5):610-9. doi: 10.1093/bja/aeq226. Epub 2010 Sep 28.

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
Background	Rocuronium	Other / unclassified	0.1 mg/kg	Intravenous
Background	Rocuronium	Other / unclassified	0.2 mg/kg	Intravenous
Background	Vecuronium	Small molecule	0.02 mg/kg	Intravenous
Background	Vecuronium	Small molecule	0.03 mg/kg	Intravenous

Indications

No indication recorded.