At a glance
ClinicalIndex Comparison Record- ✓ASA physical status class 1-3
- ✓Age 20-64 years
- ✓Caucasian ethnicity
- ✓Scheduled for elective surgery requiring neuromuscular blockade, supine position, sevoflurane anesthesia, anticipated duration 1.5-3 hours
- ✕Difficult intubation anticipated due to anatomical malformations
- ✕Neuromuscular disorders impairing neuromuscular blockade
- ✕Significant renal dysfunction (creatinine >1.6 mg/dL)
- ✕Severe hepatic dysfunction
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi -Center, Randomized, Open -Label, Prospective Bridging, Parallel Dose-Finding Trial Comparing Efficacy, Safety and Pharmacokinetics of 5 Doses of Org 25969 Administered at 1-2 PTC After Rocuronium or Vecuronium in Japanese and Caucasian Subjects. Part B: Caucasian Subjects.
In Brief
A Phase 2 clinical trial evaluating Sugammadex for Anesthesia, General. Completed, enrolled 102 participants.
Detailed Summary
The objective of the trial was to establish the dose-response relation of sugammadex given as a reversal agent of rocuronium or vecuronium at 1-2 Post-Tetanic Count (PTC) during sevoflurane anesthesia for Caucasian participants
Study Details
Timeline
Interventions
After induction of anesthesia an intubation dose of a neuromuscular blocking agent (NMBA) was administered IV: either 0.9 mg/kg rocuronium (arms 1-5) or 0.1 mg/kg vecuronium (arms 6-10). Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 the randomized single dose of sugammadex (0.5 to 8.0 mg/kg) IV was administered.