NCT00751179

Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Participants Undergoing Short Surgical Procedures (19.4.319)(P05700 AM2)(COMPLETED)

A Multi-center, Randomized, Parallel Group, Comparative, Active Controlled, Safety Assessor Blinded Trial in Adult Subjects Comparing Rocuronium Plus Sugammadex Versus Succinylcholine Alone in Subjects Undergoing Short Surgical Procedures in Out-patient Surgicenters

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A multi-center, randomized, parallel group, comparative, active controlled, safety assessor blinded trial in adult subjects comparing rocuronium plus sugammadex versus succinylcholine alone in subjects undergoing short surgical procedures in out-patient surgicenters. The primary objective was to evaluate changes in plasma potassium levels after treatment with rocuronium, sugammadex, or succinylcholine in adult subjects scheduled for short surgical procedures in out-patient surgicenters.

Conditions

• Neuromuscular Blockade

Interventions

Type	Name	Description
DRUG	rocuronium	A single bolus intubation dose of 0.6 mg/kg rocuronium will be administered following induction of anesthesia and if required, single bolus dose(s) of 0.15 mg/kg rocuronium will be administered to maintain the neuromuscular block.
DRUG	sugammadex	At the end of the surgical procedure at a target depth of neuromuscular blockade of at least 1-2 Post-Tetanic Count (PTC), 4.0 mg/kg of sugammadex will be administered.
DRUG	succinylcholine	A single bolus intubation dose of 1.0 mg/kg succinylcholine will be administered following induction of anesthesia and the subject is allowed to recover spontaneously from the neuromuscular blockade.

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-09-11
• Last updated: 2015-06-30
• Results posted: 2012-03-20