Amisulpride, effective rescue treatment for postoperative nausea or vomiting after failed prophylaxis

New Delhi: A single dose of 10-mg intravenous amisulpride, a dopamine D₂/D₃-antagonist, is safe and more effective than placebo as a rescue treatment of postoperative nausea or vomiting after a failed prior prophylaxis -- is the finding of a recent study published in the journal Anesthesiology. However, a 5 mg dose was not superior to placebo.

Antiemetics, commonly used for the prevention of postoperative nausea or vomiting, have an appreciable failure rate. Currently, there is no standardized rescue treatment of postoperative nausea or vomiting after failed prophylaxis.

Ashraf S. Habib, From the Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina, and colleagues designed this prospective, randomized, double-blind, parallel-group, placebo-controlled, multicenter study to test the hypothesis that intravenous amisulpride is superior to placebo at treating established postoperative nausea or vomiting after failed prophylaxis.

For the purpose, the researchers enrolled a total of 2,285 adult patients at 23 sites in Canada, France, Germany, and the United States who underwent surgery under general inhalational anesthesia and receiving standard antiemetic prophylaxis. 702 patients experienced postoperative nausea or vomiting in the 24-h period after surgery and were randomized to receive a single dose of 5 or 10 mg intravenous amisulpride or matching placebo.

The primary endpoint was a complete response, defined as no emesis or rescue antiemetic use for 24 h after study drug administration, excluding emesis in the first 30 min.

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Key findings of the study include:

• Complete response occurred in significantly more patients receiving 10 mg amisulpride (96 of 230, 41.7%) than placebo (67 of 235, 28.5%), a 13.2% difference.


• A 5-mg dose of amisulpride did not show a significant benefit (80 of 237, 33.8%); the difference from placebo was 5.2%.


• The total number of adverse events recorded and the proportion of patients with at least one adverse event were comparable between the placebo and amisulpride groups.


• No clinically relevant toxicities were observed.

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"Amisulpride had a rapid onset of action, shown by the immediate separation of the Kaplan–Meier curves. This is clinically important because the rapid resolution of nausea and vomiting can enable earlier patient mobilization and discharge from the highly resource-intensive PACU (postanesthesia care unit), offering benefits to both patients and healthcare institutions," wrote the authors.

"A single 10-mg dose of intravenous amisulpride was safe and more effective than placebo at treating established postoperative nausea or vomiting in patients failing postoperative nausea or vomiting prophylaxis," they concluded.

To read the complete study follow the link: doi:10.1097/ALN.0000000000002509