NDLI: I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial.

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I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial.

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I.V. APD421 (amisulpride) prevents postoperative nausea and vomiting: a randomized, double-blind, placebo-controlled, multicentre trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Kranke, P. Eberhart, L. Motsch, J. Chassard, D. Wallenborn, J. Diemunsch, P. Liu, N. Keh, D. Bouaziz, H. Bergis, M. Fox, G. Gan, T. J.
Description	Country affiliation: Germany Author Affiliation: Kranke P ( Department of Anaesthesia and Critical Care, University Hospital of Würzburg, Oberdürrbacher Str. 6, Würzburg 97080, Germany.)
Abstract	BACKGROUND: Postoperative nausea and vomiting (PONV) remain significant clinical problems for patients, especially nausea. The D2-antagonist droperidol was popular for prophylaxis until safety concerns limited its use. In early testing, APD421 (amisulpride for i.v. injection), a D2/D3-antagonist, has shown promising antiemetic efficacy at very low doses. We conducted a randomized, double-blind, dose-finding study to investigate APD421 in PONV prophylaxis. METHODS: Adult surgical patients with ≥2 Apfel risk factors for PONV undergoing surgery expected to last ≥1 h and receiving standard inhalation anaesthesia were randomized to receive placebo or one of three doses of APD421 (1, 5, or 20 mg) as a single i.v. administration at anaesthesia induction. The primary endpoint was PONV (vomiting/retching or antiemetic rescue) in the 24 h period after surgery. RESULTS: Two hundred and fifteen patients received study drug, 92% female and 60% with ≥3 risk factors. Groups were well balanced for baseline characteristics and risk factors. The PONV incidence was 37/54 [69%; 90% confidence interval (CI), 57-79%] in the placebo group; 28/58 (48%; 90% CI, 37-60%) with 1 mg APD421 (P=0.048); 20/50 (40%; 90% CI, 28-53%) with 5 mg (P=0.006); and 30/53 (57%; 90% CI, 44-68%) with 20 mg (P>0.1). APD421 at 5 mg also significantly improved vomiting, rescue medication use, and nausea rates. The safety profile of APD421 was similar to that of placebo at all doses, with no significant central nervous system (CNS) or cardiac side-effects. CONCLUSIONS: APD421 given i.v. before surgery is safe and effective at reducing PONV in moderate/high-risk adult surgical patients. The optimal dose tested was 5 mg.
File Format	HTM / HTML
ISSN	00070912
e-ISSN	14716771
Journal	British Journal of Anaesthesia
Issue Number	6
Volume Number	111
Language	English
Publisher	Oxford University Press
Publisher Date	2013-12-01
Publisher Place	Great Britain (UK)
Access Restriction	Open
Subject Keyword	Discipline Anesthesiology Antiemetics Therapeutic Use Dopamine Antagonists Postoperative Nausea And Vomiting Prevention & Control Sulpiride Analogs & Derivatives Anesthesia, Inhalation Administration & Dosage Adverse Effects Dose-response Relationship, Drug Double-blind Method Injections, Intravenous Postoperative Period Preanesthetic Medication Multicenter Study Randomized Controlled Trial Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Anesthesiology and Pain Medicine

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