Randomized Controlled Trial Multicenter Study
- Peter Kranke, Sergio D Bergese, Harold S Minkowitz, Timothy I Melson, David G Leiman, Keith A Candiotti, Ngai Liu, Leopold Eberhart, Ashraf S Habib, Jan Wallenborn, Anthony L Kovac, Pierre Diemunsch, Gabriel Fox, and Tong J Gan.
- From the Department of Anaesthesia and Critical Care, University Hospitals of Würzburg, Würzburg, Germany (P.K.) Department of Anesthesiology, Wexner Medical Center at the Ohio State University, Columbus, Ohio (S.D.B.) Memorial Hermann Hospital, Houston, Texas (H.S.M.) Helen Keller Hospital, Sheffield, Alabama (T.I.M.) Hermann Drive Surgical Hospital, Houston, Texas (D.G.L.) Department of Anesthesiology, Jackson Memorial Hospital, Miami, Florida (K.A.C.) Service d'Anesthésie, Hôpital Foch, Suresnes, France (N.L.) Outcomes Research Consortium, Cleveland Clinic, Ohio (N.L.) Department of Anaesthesiology and Intensive Care, Philipps University Marburg, Marburg, Germany (L.E.) Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina (A.S.H.) Department of Anesthesiology and Intensive Care, HELIOS Clinic Aue, Aue, Germany (J.W.) Department of Anesthesiology, University of Kansas Medical Center, Kansas City, Kansas (A.L.K.) Department of Anesthesiology and Resuscitation, Centre Hospitalier Universitaire of Hautepierre, Strasbourg, France (P.D.) Acacia Pharma, Cambridge, United Kingdom (G.F.) Department of Anesthesiology, Stony Brook University Medical Center, New York (T.J.G.).
- Anesthesiology. 2018 Jun 1; 128 (6): 1099-1106.
BackgroundPostoperative nausea and vomiting causes distress for patients and can prolong care requirements. Consensus guidelines recommend use of multiple antiemetics from different mechanistic classes as prophylaxis in patients at high risk of postoperative nausea and vomiting. The prophylactic efficacy of the dopamine D2/D3 antagonist amisulpride in combination with other antiemetics was investigated.MethodsThis double-blind, randomized, placebo-controlled, international, multicenter trial was conducted in 1,147 adult surgical patients having three or four postoperative nausea and vomiting risk factors. Patients were randomized to receive either intravenous amisulpride (5 mg) or matching placebo at induction of general anesthesia, in addition to one standard, nondopaminergic antiemetic, most commonly ondansetron or dexamethasone. Vomiting/retching, nausea, and use of rescue medication were recorded for 24 h after wound closure. The primary endpoint was complete response, defined as no emesis or rescue medication use in the 24-h postoperative period.ResultsComplete response occurred in 330 of 572 (57.7%) of the amisulpride group and 268 of 575 (46.6%) of the control group (difference 11.1 percentage points; 95% CI, 5.3 to 16.8; P < 0.001). The incidences of emesis (13.8% vs. 20.0%, P = 0.003), any nausea (50.0% vs. 58.3%, P = 0.002), significant nausea (37.1% vs. 47.7%, P < 0.001), and rescue medication use (40.9% vs. 49.4%, P = 0.002) were significantly lower in the amisulpride group. Adverse events and laboratory and electrocardiogram abnormalities occurred no more frequently with amisulpride than with placebo.ConclusionsIntravenous amisulpride was safe and effective as prophylaxis of postoperative nausea and vomiting when given in combination with an antiemetic from another class to adult patients at high risk for suffering postoperative nausea and vomiting undergoing elective surgery under inhalational general anesthesia.Visual AbstractAn online visual overview is available for this article at http://links.lww.com/ALN/B727.
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