TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING WITH SINGLE INTRAVENOUS DOSES OF DOLASETRON MESYLATE - A MULTICENTER TRIAL

This study was conducted to determine the efficacy and safety of four intravenous (TV) doses of dolasetron, an investigational 5-HT3 recepto r antagonist, for the treatment of postoperative nausea and/or vomitin g (PONV) after outpatient surgery under general anesthesia. This multi center, randomized, double-blind trial compared the antiemetic efficac y of 12.5, 25, 50, or 100 mg IV dolasetron with placebo over 24 h usin g complete response (no emetic episodes and no rescue medication), tim e 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 treat ment. Complete response rates for all dolasetron doses 12.5 mg (35%), 25 mg (28%), 50 mg (29%), and 100 mg (29%)-were significantly more eff ective than placebo (11%, P < 0.05). There was a significant gender in teraction for complete response (P < 0.01). Of the patients in the 25- mg and 100-mg dose groups, 12% and 13%, respectively, experienced no n ausea (VAS store < 5 mm) versus 5% in the placebo group (P < 0.05). Th ere were no clinically relevant changes in vital signs or laboratory v alues and no trends with dose for adverse events. Dolasetron is effect ive 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 com plete response; Implications: Nausea and vomiting are common problems for postsurgical patients. In this study of 620 patients undergoing su rgery, a 12.5-mg dose of intravenous dolasetron, a new serotonin-recep tor blocker, was significantly more effective than placebo in establis hed postoperative nausea and vomiting. Dolasetron 12.5 mg was as safe as placebo.