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Sugammadex Trials Demonstrate Rapid Recovery from Profound Neuromuscular Blockade During General Anesthesia
Date:10/16/2007

us complications such as muscle weakness and breathing difficulties. NMBAs are often administered during surgery to enable endotracheal intubation and provide total skeletal muscle relaxation when the surgery requires that patients' muscles are relaxed during the procedure.

Professor Caldwell added, "Also, the results of the Spectrum trial are important because it indicates that the combination of rocuronium followed by sugammadex can provide faster recovery from neuromuscular blockade than spontaneous recovery from succinylcholine, the shortest acting NMBA currently available."

About the Signal trial(1)

This profound block trial was a multicenter, parallel-group study among adult patients undergoing surgery in the supine position (patient on his/her back). Rocuronium (0.6 mg/kg) was administered for intubation, followed by maintenance doses (0.15 mg/kg) as required. When reversal was needed, patients were randomized to receive either sugammadex (4.0 mg/kg) or neostigmine (70 micrograms/kg) plus glycopyrrolate (14 micrograms/kg).

In the intent-to-treat population (37 patients in each group), the mean time to recovery of the T(4)/T(1) ratio to 0.9 with sugammadex was 2.9 minutes, compared to 50.4 minutes with neostigmine/glycopyrrolate (p< 0.0001), a confirmed 17 times faster reversal with sugammadex.

The most frequently reported adverse events (AEs) for the sugammadex and neostigmine groups regardless of relationship to the study drug were procedural pain (70 vs. 76%) and nausea (38 vs. 50%). For both groups no serious drug-related adverse events were reported. Clinical chemistry results were similar between groups. No patients had clinical evidence of recurarization or residual curarization.

About the Spectrum trial(2)

In this second profound block trial, 110 patients undergoing elective surgery requiring short duration of neuromuscular relaxation were randomized to receive either an intubating dose of rocuronium 1.2 mg/kg
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SOURCE Organon
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