Dolasetron for the prevention of postoperative nausea and vomiting following outpatient surgery with general anaesthesia: a randomized, placebo-controlled study

In a multicentre, randomized, double-blind, placebo-controlled dose-ranging study, 1030 patients undergoing outpatient surgery with general anaesthesi a received i.v. dolasetron mesylate (12.5, 25, 50, or 100 mg) or placebo. T he principal outcome measure was the proportion of patients who were free o f emesis or rescue medication for the 24-h period after the study drug was given; the subsidiary outcome measure was survival time without rescue medi cation. Effects on nausea were quantified using a visual analogue scale. Co mpared with placebo, a complete response was significantly higher when all four dolasetron doses were combined (49% vs. 58%, P = 0.025). In females, d olasetron, 12.5-mg, dolasetron provided maximum clinical benefit (effective ness compared with adverse events), with no additional benefit in complete response rates or nausea visual analogue scale scores at higher doses. No s ignificant differences were observed in complete response for any dolasetro n dose in males compared with placebo. The majority of adverse events repor ted were mild or moderate. Dolasetron provided well-tolerated, safe, and ef fective prophylaxis for post-operative nausea and vomiting with maximum eff ectiveness observed at a dose of 12.5 mg.