Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)

Phase 3 Completed 86 enrolled Merck Sharp & Dohme LLC

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary disease. All drug administration will be via the intravenous (IV) route.

Timeline

Start: 2005-10-27
Primary completion: 2006-08-21
Completion: 2006-09-09

Publications

Amao R, Zornow MH, Cowan RM, Cheng DC, Morte JB, Allard MW. Use of sugammadex in patients with a history of pulmonary disease. J Clin Anesth. 2012 Jun;24(4):289-97. doi: 10.1016/j.jclinane.2011.09.006.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Sugammadex	Other / unclassified	2 mg/kg	Intravenous
Subject	Sugammadex	Other / unclassified	4 mg/kg	Intravenous
Background	Rocuronium	Other / unclassified	0.15 mg/kg	Intravenous

Indications

No indication recorded.