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Can a pill stop Post-Surgery nausea? trial tests oral amisulpride
NCT ID NCT06887621
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing whether adding a 50 mg oral dose of amisulpride to standard anti-nausea drugs can prevent nausea and vomiting after gynecological surgery. The trial enrolls 276 women at high risk for postoperative nausea and vomiting who are having laparoscopic hysterectomy for benign conditions. Participants receive either oral amisulpride or a placebo one hour before anesthesia, along with intravenous ondansetron and dexamethasone. The goal is to see if the oral drug improves complete response, meaning no nausea, vomiting, or need for rescue medication in the first 24 hours after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- oral amisulpride, an anti-nausea drug
- What this could lead to
- If it works, oral amisulpride could offer an affordable, painless way to prevent nausea and vomiting after surgery, especially in places where the intravenous form is not available.
- What could go wrong
- This is a Phase 2 trial, so it may not show a clear benefit. Oral drugs can be absorbed differently than IV drugs, and adding a third anti-nausea medicine could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 276 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Laparoscopic hysterectomy to treat benign conditions. * High risk for PONV according to the Apfel Score: scores 3 or 4. * American Society of Anesthesiology (ASA) physical status: 1 or 2. Exclusion Criteria: * Cognitive or psychiatric conditions impairing consent or compliance. * Incapability of using the mobile app MyCapp for data collection. * History of allergy or sensibility to any medication included in the protocol: amisulpride, dexamethasone, ondansetron, fentanyl, midazolam, bupivacaine, morphine, propofol, rocuronium, sevoflurane, ephedrine, metaraminol, remifentanil, metamizole, ketoprofen, sugammadex, dimenhydrinate, pyridoxine hydrochloride, tramadol, dimethicone. * Inability to swallow medications. * Current use of typical or atypical antipsychotic medications. * Gestation or lactation. * Clinically significant cardiac arrhythmia or long QT syndrome documented. * Hypokalemia (K+ \< 3.5 mmol/L) * Prolactin-dependent tumors. * Pheochromocytoma. * Parkinson's disease. * Nausea or vomiting in the 24 hours before surgery. * Therapeutic use of antiemetics, including corticosteroids. * Emetogenic oncological therapy (above 10% probability of causing vomiting) in the 2 weeks before surgery. * Persistent pre-operative hypotension on the day of surgery, defined as systolic blood pressure \< 100 mmHg on at least 2 consecutive measurements. * Mechanical ventilation plan or need for a naso/orogastric tube after surgery. * Intestinal endometriosis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Hospital da Mulher
São Paulo, São Paulo, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.