NCT00298831

Use of Sugammadex at the End of Case in Routine Anesthesia (MK-8616-023)

A Multicenter, Open Label, Phase IIIa Trial to Evaluate the Efficacy and Safety of Org 25969 When Used at the End of a Surgical Procedure to Reverse the Neuromuscular Block Induced by Rocuronium Following Routine Anesthesia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evaluation is part of the study.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	Sugammadex	At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered.
DRUG	Rocuronium	Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was/were administered.

Timeline

• Start date: 2005-10-27
• Primary completion: 2006-05-22
• Completion: 2006-05-22
• First posted: 2006-03-03
• Last updated: 2019-03-27
• Results posted: 2019-03-15