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

return of the train-of-four (TOF) ratio to 0.9. Profound neuromuscular blockade reversal with sugammadex 4 mg/kg was about 17 times faster than with neostigmine 70 mcg/kg (geometric mean times were 2.9 minutes versus 50.4 minutes, respectively [P<0.0001], while median times were 2.7 minutes versus 49.0 minutes). In the study, 97 percent of sugammadex-treated patients recovered to a TOF ratio of 0.9 within five minutes of administration. In contrast, 73 percent of neostigmine-treated patients did not recover until 30-60 minutes, and a large proportion (23 percent) did not recover to a TOF ratio of 0.9 until more than 60 minutes after neostigmine administration.

The study enrolled surgical patients, aged 18 years or older with American Society of Anesthesiology physical status I-IV. Seventy-four patients were randomized to receive sugammadex (4.0 mg/kg) or neostigmine (70 mcg/kg) plus glycopyrrolate (14 mcg/kg) and completed the study. Anesthetized patients received an intubating dose of rocuronium (0.6 mg/kg), with maintenance doses (0.15 mg/kg) as required. Neuromuscular monitoring was performed by acceleromyography.

In the study, sugammadex was well tolerated in the 37 patients who received the treatment, and its safety profile overall was comparable with that of neostigmine. Safety data from the study showed that the most frequently reported adverse events (AEs) for patients in both groups included procedural pain, nausea and incision-site complications. Serious adverse events (SAEs) were reported for two patients in the sugammadex group (postoperative infection and postoperative ileus) and three patients in the neostigmine group (nausea/pain/dyspnea, gastric perforation/procedural complication and postoperative ileus). No SAE was considered study drug-related. Only one patient (neostigmine group) discontinued from the study because of two SAEs (gastric perforation/procedural complication) and subsequently recovered. No cases of hypersensitivity w
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SOURCE Schering-Plough Corporation
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