At a glance
ClinicalIndex Comparison Record- ✓ASA physical status 1-4
- ✓Age 18 years or older
- ✓Scheduled for general anesthesia with rocuronium or vecuronium for intubation and neuromuscular blockade maintenance
- ✓Surgical procedure in supine position
- ✕Expected difficult intubation due to anatomical malformations
- ✕Suspected neuromuscular disorder impairing neuromuscular blockade or significant renal dysfunction
- ✕History of malignant hyperthermia (personal or family)
- ✕Known or suspected allergy to narcotics, muscle relaxants, or other anesthesia medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi -Center Randomized Parallel Group Comparative Active Controlled Safety Assessor Blinded Phase 3a Pivotal Trial in Adult Subjects Comparing Org 25969 With Neostigmine as Reversal Agents of a Neuromuscular Block Induced by Rocuronium or Vecuronium at Reappearance of T2
In Brief
A Phase 3 clinical trial evaluating Sugammadex and Neostigmine for Anesthesia, General. Completed, enrolled 198 participants.
Detailed Summary
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) by 2.0 mg/kg sugammadex (Org 25969) compared to 50 ug/kg neostigmine.
Study Details
Timeline
Interventions
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered
After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered