This study was conducted to determine the efficacy and safety of four intravenous (I.V.) doses of
dolasetron, an investigational
5-HT3 receptor antagonist, for the treatment of
postoperative nausea and/or
vomiting (
PONV) after
outpatient surgery under
general anesthesia. This multicenter, randomized, double-blind trial compared the
antiemetic efficacy of 12.5, 25, 50, or 100 mg I.V.
dolasetron with placebo over 24 h using complete response (no
emetic episodes and no rescue medication), time to first
emetic episode or rescue medication, and patient
nausea and satisfaction with
antiemetic therapy as rated by visual analog scale (VAS). Of 1557 patients enrolled, 620 patients were eligible for treatment. Complete response rates for all
dolasetron doses--12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)--were significantly more effective than placebo (11%, P < 0.05). There was a significant gender interaction for complete response (P < 0.01). Of the patients in the 25-mg and 100-mg dose groups, 12% and 13%, respectively, experienced no
nausea (VAS score < 5 mm) versus 5% in the placebo group (P < 0.05). There were no clinically relevant changes in vital signs or laboratory values and no trends with dose for adverse events.
Dolasetron is effective for treating
PONV and has an adverse event profile similar to that of placebo. The 12.5-mg dose was as effective as larger doses for complete response.
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