NCT00474253

Comparison of Recovery From Rocuronium 1.2 mg/kg Followed by Sugammadex (Org 25969) 16 mg/kg at 3 Minutes With Recovery From Succinylcholine 1.0 mg/kg (19.4.303)(P05946)(MK-8616-026)

A Multicenter, Randomized, Parallel Group, Comparative, Active-Controlled, Safety-Assessor Blinded, Phase IIIa, Trial, in Adult Subjects Comparing Recovery From 1.2 mg.Kg-1 Rocuronium Followed by 16 mg.Kg-1 Org 25969 at 3 Minutes With Recovery From 1.0 mg.Kg-1 Succinylcholine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	Sugammadex	Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex
DRUG	Succinylcholine	Single bolus IV dose of 1.0 mg/kg succinylcholine
DRUG	Rocuronium	Single bolus IV dose of 1.2 mg/kg rocuronium

Timeline

• Start date: 2006-02-10
• Primary completion: 2006-08-22
• Completion: 2006-09-09
• First posted: 2007-05-16
• Last updated: 2019-04-11
• Results posted: 2019-03-29

Regulatory

• FDA-regulated drug study