Last updated on January 2019

Safety of Sugammadex for the Reversal of Neuromuscular Blockade in American Society of Anesthesiologists (ASA) Class 3 or 4 Participants (MK-8616-145)

Brief description of study

This is a randomized, active comparator-controlled, parallel-group, multi-site, double-blind safety trial of sugammadex (MK-8616) for the reversal of neuromuscular blockade (NMB) induced by rocuronium or vecuronium in adult ASA Physical Status Class 3 and 4 participants. The first primary objective of this study is to characterize the incidence of treatment emergent sinus bradycardia, treatment emergent sinus tachycardia, or other treatment emergent cardiac arrhythmias after administration of sugammadex. The second primary objective of this study is to evaluate the general safety of sugammadex in a population of ASA Class 3 and 4 subjects in a surgical setting.

Clinical Study Identifier: NCT03346057

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Study Coordinator

A.O. Krankenhaus Dornbirn ( Site 1151)
Dornbirn, Austria
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Recruitment Status: Open

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