Status:
UNKNOWN
Sugammadex Efficacy and Safety for Reversal of Pipecuronium-induced Neuromuscular Blockade
Lead Sponsor:
Central Clinical Hospital #1 of LLC Russian Railways
Conditions:
Adult Subjects Undergoing Abdominal Surgery Under General Anesthesia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 undergoi...
Detailed Description
Sugammadex is the first selective relaxant binding agent indicated for reversal of rocuronium and vecuronium-induced blockade. At the same time sugammadex is able to form the complexes with other ami...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT01424488
Start Date
September 1 2011
End Date
February 1 2012
Last Update
August 29 2011
Active Locations (1)
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1
Central Clinical Hospital #1 of LLC "Russian Railroad"
Moscow, Moscow, Russia, 125367