Your surgeons & anesthetists might find this interesting
I thought you might find this interesting. Let me know if you need help
getting a copy of the article (link to article at end of message).
Intravenous Amisulpride for the Prevention of Postoperative Nausea and
Vomiting: Two Concurrent, Randomized, Double-blind, Placebo-controlled
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.
Full-text available in Ovid from any hospital computer
or through your "My Athens" account (let me know if you need help
(if the URL line breaks be sure to copy everything inside the
angle brackets into your browser's address box)
If you do not want to receive emails like this reply to this email with the
words "delete from list" and I will remove you from my distribution lists.
If I can be of further assistance please ask.
Alice E. Hadley, MLS, AHIP(D)
Your Personal Medical INFORMATION Shopper for
patient care, education, and research
ORCID iD: orcid.org/0000-0002-2951-6196
Medical Library 344-9250
cell 678-1353 fax 344-9663
DSN 315 344-9250
US Naval Hospital, Guam
PSC 455 Box 208
FPO, AP 96540
< [log in to unmask] >
<[log in to unmask]>
Literature Search Service: Don't have time for a patient care question?
Working on a JAGMAN or Root Cause Analysis? If you can't find the
information you're looking for why not try the Library? I can perform
searches for you. Simply email me and ask for a literature search.
To set up a meeting try "Meeting Planner"
The more you know the better you heal.
"FOR OFFICIAL USE ONLY (FOUO) -PRIVACY SENSITIVE. Any misuse or
unauthorized disclosure may result in both civil and criminal penalties".