Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade
Status:
Unknown status
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
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
Phase:
Phase 4
Details
Lead Sponsor:
Central Clinical Hospital #1 of LLC Russian Railways