NCT00559468

Sugammadex After Continuous Infusion of Rocuronium During Sevoflurane and Propofol Anesthesia (P05949; MK-8616-028)

A Multi -Center, Randomized, Parallel Group, Safety Assessor Blinded Trial Comparing Efficacy and Safety of 4.0 mg.Kg-1 Sugammadex , Administered at T1 3-10% After Continuous Infusion of Rocuronium, and Pharmacokinetics of Rocuronium, Between Subjects Receiving Maintenance Anesthesia Using Propofol and Subjects Receiving Maintenance Anesthesia Using Sevoflurane

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 20 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	Sugammadex	Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
DRUG	Rocuronium	Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
DRUG	Sevoflurane	Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
DRUG	Propofol	Propofol IV administered for induction and maintenance of anesthesia, based on randomization.

Timeline

• Start date: 2006-12-07
• Primary completion: 2007-03-02
• Completion: 2007-03-02
• First posted: 2007-11-16
• Last updated: 2019-11-25
• Results posted: 2019-02-08