Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade

• Status: Unknown status
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Clinical Hospital #1 of LLC Russian Railways
• Treatments: Pipecuronium

Criteria

Inclusion Criteria:

• Subjects of ASA class 1-3

• Subjects of age ≥ 18 years

• Subjects undergoing abdominal surgery under general anesthesia who receives succinylcholine for tracheal intubation and pipecuronium for maintenance of neuromuscular blockade

• Subjects who have given written informed consent

Exclusion Criteria:

• Subjects in whom a difficult intubation is expected

• Subjects known or suspected to have neuromuscular disorders affecting NMB

• Subjects known or suspected to have a significant renal dysfunction or a severe hepatic dysfunction

• Subjects known or suspected to have (family) history of malignant hyperthermia

• Subjects known or suspected to have an allergy to opioids, muscle relaxants or other medication used during general anesthesia

• Female subjects who are pregnant

• Female subjects who are breast-feeding