At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Sugammadex, Rocuronium, and 2 other interventions for Anesthesia, General. Completed, enrolled 52 participants.
Detailed 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.
Study Details
Timeline
Interventions
Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium
Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium
Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization.
Propofol IV administered for induction and maintenance of anesthesia, based on randomization.