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AMBULATORY ANESTHESIA

A Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Three Different Doses of Palonosetron Versus Placebo for Preventing Postoperative Nausea and Vomiting

Keith A. Candiotti, MD^*, Anthony L. Kovac, MD, Timothy I. Melson, MD, Giuseppina Clerici, MD, Tong Joo Gan, MB, FRCA^||, and The Palonosetron 04–06 Study Group

From the *Departments of Anesthesiology, Perioperative Medicine and Pain Management, University of Miami, Miami, Florida; Department of Anesthesiology, University of Kansas Medical Center, Kansas City, Kansas; Helen Keller Memorial Hospital, Sheffield, Alabama; Research and Development Department, Helsinn Healthcare SA, Lugano, Switzerland; and ||Department of Anesthesiology, Duke University Medical Centre, Durham, North Carolina.

Address correspondence and reprint requests to Giuseppina Clerici, MD, P.O. Box 357 – 6915 Pambio-Noranco (Lugano) – Switzerland. Address e-mail to gcl{at}helsinn.com.

BACKGROUND: In this randomized, double-blind study we assessed the efficacy and safety of three different doses of the 5-HT₃ receptor antagonist palonosetron, compared with placebo, on the incidence and severity of postoperative nausea and vomiting (PONV) for 72 h postsurgery.

METHODS: Five hundred seventy-four patients undergoing either outpatient abdominal or gynecological laparoscopic surgery were stratified according to gender, history of PONV or motion sickness, and nonsmoking status. Patients with 2 PONV risk factors were eligible and randomized to receive one of three doses of IV palonosetron (0.025 mg, 0.050 mg, or 0.075 mg) or placebo immediately prior to induction of anesthesia. Co-primary efficacy end-points included complete response (CR: no emetic episodes and no rescue medication) during the 0 to 24 h and 24 to 72 h postoperative time intervals.

RESULTS: A dose-response trend in the proportion of patients with a CR was observed with increasing doses of palonosetron in the first 24 hrs. CR rates for placebo and palonosetron 0.075 mg were 26% and 43%, respectively, for the 0 to 24 h postoperative interval (P = 0.004), and 41% and 49%, respectively, for the 24 to 72 h interval (P = 0.188). Compared with placebo, palonosetron 0.075 mg was associated with a significant downward shift toward less intense nausea (P = 0.042) and with significant reduction in the impact of PONV on patient functioning (P = 0.004) during the 0 to 24 h interval.

CONCLUSIONS: A single 0.075-mg IV dose of palonosetron significantly increased the CR rate (no emetic episodes and no rescue medication) from 0 to 24 h, decreased nausea severity and patients experienced significantly less interference in their postoperative function due to PONV.

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