A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period.

ABSTRACT

PURPOSE: We performed a multicenter, randomized, double-blind trial to assess the efficacy and safety of a single, fixed, intravenous dose of palonosetron (0.075 mg) in the treatment of established postoperative nausea and vomiting (PONV). METHODS: Three hundred and eighty-four patients who had at least one risk factors of PONV and underwent surgery under general anesthesia were screened. Those who developed PONV were randomized to receive either 0.075 mg intravenous palonosetron or a placebo. The incidence of nausea and vomiting, severity of nausea, requirements for rescue anti-emetics, and adverse effects at 2, 24, and 72 h after drug administration were evaluated. Complete response (CR) and complete control (CC) rate were compared for 24 and 72 h. RESULTS: Among the 384 patients, 152 (39.6 %) developed PONV and were randomized to either the palonosetron (n = 75) or placebo (n = 77) group. The number of patients with CR at 24 and 72 h was higher in the palonosetron group than the placebo group [0-24 h n = 49 (68.1 %) vs. n = 30 (40.5 %), p < 0.001; 0-72 h n = 47 (65.3 %) vs. n = 28 (37.8 %), p < 0.001]. The incidence of PONV at 2, 24, and 72 h periods was lower in the palonosetron group than the placebo group (29.2, 45.8, and 50.0 % in the palonosetron group vs. 50.0, 62.2, and 66.2 % in the placebo group, p = 0.010, 0.048, 0.047, respectively). The incidence of adverse events was not different between the groups. CONCLUSION: A single 0.075 mg IV dose of palonosetron effectively increased the CR rates at 24 and 72 h in these moderate-risk patients with established PONV.