Safety and Efficacy of Sugammadex for Neuromuscular Blockade Reversal

Abstract

Since its first human use in 2005, the γ-cyclodextrin sugammadex (Org 25969) has had the potential to become the reversal agent of choice, for rocuronium- or vecuronium-induced neuromuscular blockade. Sugammadex binds to the aminosteroid neuromuscular blocker, encapsulating it and extracting it from the neuromuscular junction, effectively ceasing activity and allowing neuromuscular transmission to recover rapidly. Phases I–III and subsequent trials have found sugammadex to be safe and effective in a wide range of doses and for the reversal of a range of depth of muscle relaxation in healthy volunteers and a variety of disease states. Sugammadex use may allow refinement of anesthetic practice and improvement in surgical conditions, through the maintenance of deep neuromuscular blockade right to the end of surgery, with subsequent rapid reversal. Debate remains about the use of sugammadex in the treatment of rocuronium anaphylaxis and airway emergencies. The high price of sugammadex currently prohibits its routine use, but if the price falls, after expiry of its patent, it may become cost-effective as a readily available agent in certain specific clinical situations. Serious adverse reactions have occurred in less than 1% of patients and are most commonly because of hypersensitivity. No deaths have been reported, but caution is advised in neonates, pediatrics, and pregnancy where data are lacking.