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Sugammadex Study First to Show Rapid Reversal of Profound Rocuronium-Induced Muscle Relaxation is Possible
Date:10/28/2008

blinded study that compared the efficacy and safety of sugammadex versus neostigmine/glycopyrrolate in the reversal of profound rocuronium-induced neuromuscular blockade. Traditionally, reversal of nondepolarizing neuromuscular blocking agents (NMBAs) such as rocuronium or vecuronium has been achieved by using acetylcholinesterase inhibitors, such as neostigmine. However, these older agents cannot rapidly reverse profound neuromuscular blockade.

Neuromuscular blockade plays several critical roles in general anesthesia. Anesthesiologists use muscle relaxation to improve surgical conditions and to facilitate intubation and mechanical ventilation. Reversal agents reverse the effects of muscle relaxants, enabling patients to regain normal muscle function sooner and breathe on their own again.

Studies have shown that in clinical practice, patients are often extubated before complete recovery has occurred, leaving the patients at risk of associated postoperative complications such as airway obstruction or pulmonary complications. Residual neuromuscular blockade, which is an important cause of NMBA-associated morbidity in surgical patients, was not reported in any patient in this study.

"These results demonstrate the efficacy of sugammadex in rapidly reversing profound rocuronium-induced neuromuscular blockade, an option that is not possible with conventional reversal agents," said Robert J. Spiegel, M.D., chief medical officer and senior vice president, Schering-Plough Research Institute. "This study shows that sugammadex offers advantages over neostigmine and may help improve anesthesia management in the millions of surgeries where muscle relaxation agents are used."

Key Findings

In the Signal study, sugammadex or neostigmine was administered at reappearance of 1-2 post-tetanic counts (profound neuromuscular blockade). The primary efficacy endpoint of the study was time from sugammadex or neostigmine/glycopyrrolate administration to
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SOURCE Schering-Plough Corporation
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