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Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial.

Publication ,  Journal Article
Kranke, P; Bergese, SD; Minkowitz, HS; Melson, TI; Leiman, DG; Candiotti, KA; Liu, N; Eberhart, L; Habib, AS; Wallenborn, J; Kovac, AL; Fox, G ...
Published in: Anesthesiology
June 2018

BACKGROUND: Postoperative 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. METHODS: This 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. RESULTS: Complete 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. CONCLUSIONS: Intravenous 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 ABSTRACT: An online visual overview is available for this article at http://links.lww.com/ALN/B727.

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Published In

Anesthesiology

DOI

EISSN

1528-1175

Publication Date

June 2018

Volume

128

Issue

6

Start / End Page

1099 / 1106

Location

United States

Related Subject Headings

  • Risk Factors
  • Postoperative Nausea and Vomiting
  • Middle Aged
  • Male
  • Internationality
  • Humans
  • Female
  • Double-Blind Method
  • Dopamine Antagonists
  • Antipsychotic Agents
 

Citation

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Kranke, P., Bergese, S. D., Minkowitz, H. S., Melson, T. I., Leiman, D. G., Candiotti, K. A., … Gan, T. J. (2018). Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology, 128(6), 1099–1106. https://doi.org/10.1097/ALN.0000000000002133
Kranke, Peter, Sergio D. Bergese, Harold S. Minkowitz, Timothy I. Melson, David G. Leiman, Keith A. Candiotti, Ngai Liu, et al. “Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial.Anesthesiology 128, no. 6 (June 2018): 1099–1106. https://doi.org/10.1097/ALN.0000000000002133.
Kranke P, Bergese SD, Minkowitz HS, Melson TI, Leiman DG, Candiotti KA, et al. Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2018 Jun;128(6):1099–106.
Kranke, Peter, et al. “Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial.Anesthesiology, vol. 128, no. 6, June 2018, pp. 1099–106. Pubmed, doi:10.1097/ALN.0000000000002133.
Kranke P, Bergese SD, Minkowitz HS, Melson TI, Leiman DG, Candiotti KA, Liu N, Eberhart L, Habib AS, Wallenborn J, Kovac AL, Diemunsch P, Fox G, Gan TJ. Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2018 Jun;128(6):1099–1106.

Published In

Anesthesiology

DOI

EISSN

1528-1175

Publication Date

June 2018

Volume

128

Issue

6

Start / End Page

1099 / 1106

Location

United States

Related Subject Headings

  • Risk Factors
  • Postoperative Nausea and Vomiting
  • Middle Aged
  • Male
  • Internationality
  • Humans
  • Female
  • Double-Blind Method
  • Dopamine Antagonists
  • Antipsychotic Agents