| Статус: | Unknown status |
| Фаза: | Phase 4 |
| Начало: | 1 сентября 2011 г. |
| Окончание: | 1 февраля 2012 г. |
| Описание: | Primary objectives: 1. to investigate the efficacy of sugammadex in dose of 4 mg/kg administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade in subjects undergoing abdominal surgery under general anesthesia 2. to evaluate the safety and tolerability of a single dose of 4 mg/kg sugammadex administered at reappearance of T2 for reversal of pipecuronium-induced neuromuscular blockade Secondary objectives: 1. to evaluate the time from the start of sugammadex or placebo administration to the time of extubation and to the time of recovery of TOF ratio to ≥ 0.9 Exploratory objectives: 1. to evaluate the Operating Room (OR) and Post Anesthetic Care Unit (PACU) length of stay after the end of surgery in subjects with pipecuronium induced neuromuscular blockade reversed by 4.0 mg.kg-1 sugammadex compared to placebo (saline) 2. compare the number of patients extubated in the OR after the reversal by sugammadex or placebo, evaluate the TOF ratio at the time of extubation Clinical hypothesis: 1. Sugammadex has to be effective and well tolerated for reversal of pipecuronium-induced blockade |
| смотреть на ClinicalTrials.gov |