Your surgeons & anesthetists might find this interesting


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------------------------
Intravenous Amisulpride for the Prevention of Postoperative Nausea and
Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled
Trials.
Gan TJ(1), Kranke P, Minkowitz HS, Bergese SD, Motsch J, Eberhart L, Leiman
DG, Melson TI, Chassard D, Kovac AL, Candiotti KA, Fox G, Diemunsch P.

Anesthesiology. 2017 Feb;126(2):268-275. PMID: 27902493


BACKGROUND: Two essentially identical, randomized, double-blind,
placebo-controlled, parallel-group phase III studies evaluated the efficacy
of intravenous amisulpride, a dopamine D2/D3 antagonist, in the prevention
of postoperative nausea and vomiting in adult surgical patients.
METHODS: Adult inpatients undergoing elective surgery during general
anesthesia and having at least two of the four Apfel risk factors for
postoperative nausea and vomiting were enrolled at 9 U.S. and 10 European
sites. A single 5-mg dose of amisulpride or matching placebo was given at
induction of anesthesia. The primary endpoint was complete response, defined
as no vomiting/retching and no use of antiemetic rescue medication in the
24-h postoperative period. Nausea incidence was a secondary endpoint.

RESULTS: Across the two studies, 689 patients were randomized and dosed with
study medication, of whom 626 were evaluable per protocol. In the U.S.
study, 46.9% (95% CI, 39.0 to 54.9) of patients achieved complete response
in the amisulpride group compared to 33.8% (95% CI, 26.2 to 42.0) in the
placebo group (P = 0.026). In the European study, complete response rates
were 57.4% (95% CI, 49.2 to 65.3) for amisulpride and 46.6% (95% CI, 38.8 to
54.6) for placebo (P = 0.070). Nausea occurred less often in patients who
received amisulpride than those who received placebo. There was no
clinically significant difference in the safety profile of amisulpride and
placebo; in particular, there were no differences in terms of QT
prolongation, extrapyramidal side effects, or sedation.

CONCLUSIONS: One of the two trials demonstrated superiority, while pooling
both in a post hoc change to the plan of analysis supported the hypothesis
that amisulpride was safe and superior to placebo in reducing the incidence
of postoperative nausea and vomiting in a population of adult inpatients at
moderate to high risk of postoperative nausea and vomiting.

DOI: 10.1097/ALN.0000000000001458


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