A Randomized, Double Blind Study to Evaluate the Efficacy of Palono- setron with Dexamethasone Versus Palonosetron Alone for Prevention of Post-Operative Nausea and Vomiting in Subjects Undergoing Bariatric Surgeries with High Emetogenic Risk

Introduction: Postoperative (PONV) and postdischarge (PDNV) nausea and vomiting are common (60-70%) after bariatric surgery. Palonosetron (Pal), a novel 5-HT3 antagonist, is an effective antiemetic with a prolonged duration of action in the setting of PDNV. We hypothesized that combination therapy with Palonosetron (Pal) and dexamethasone (Dex) would improve treatment in comparison to Palonosetron alone in patients at high risk for PONV. Methods: In this study, patients undergoing bariatric laparoscopic surgery under general anesthesia, a subgroup of a larger Phase IV clinical trial of patients who had laparoscopic surgery, were randomized to 8 mg Dex + 0.075mg Pal or saline + 0.075mg Pal. Data was collected postoperatively at 2, 6, 24 and 72 hrs. A Functional Living Index-Emesis (QOL-FLIE) test was administered at 96 hrs. Results: We enrolled 76 ASA 1-2 patients with at least 3 PONV risk factors. Both randomization groups had a low incidence of vomiting in the PACU (Pal, 0.0%; Pal + Dex, 5.4%) as well as at 72 hours (0.0% both groups). Complete response (no vomiting, no rescue medication) was not different between treatment groups at any time intervals. Cumulative success rates over the entire 72 hrs were 60.4% (Pal alone) vs. 60.0% (Pal + Dex). Nausea scores (4 point ordinal scale) were not different between groups for any time intervals. Cumulative success scores for nausea (score = “none”; 0-72 hrs) were 41.9% for the Pal group, and 55.2% for the Pal+ Dex group. The Pal + Dex group showed a trend toward greater satisfaction on the QOL-FLIE scores with the greatest differences in the “nausea domain”. Discussion: The combination therapy (Pal + Dex) did not significantly reduce the incidence of PONV or PDNV when compared with Pal alone although a trend was observed indicating the possible increased efficacy of multi-drug therapy. There was no change in comparative efficacy over 72 hrs, possibly due to the low incidence of PDNV in both groups.