Patients at high risk for postoperative nausea and vomiting undergoing gynecological surgery: efficacy of oral amisulpride in combination with intravenous ondansetron and dexamethasone - a parallel-group randomized trial
NCT ID NCT06887621
First seen Sep 09, 2026 · Last updated Sep 09, 2026
Summary
Amisulpride is a potent antagonist of dopamine D2 and D3 receptors, both implicated in the emetic response when activated. It is currently used intravenously for the prevention of chemotherapy-induced and postoperative nausea and vomiting (PONV), but this route has a short half-life time of 4 to 5 hours, could be expensive, causes infusion-related pain, and is not available in Brazil. Some of these limitations could be overcome by the preemptive use of an oral formulation. At present, there are no data regarding the use of oral amisulpride for PONV, which is an affordable and painless option with half-life time of 12 hours. We propose a quadruple-blind clinical trial involving patients undergoing gynecological surgery aged 18 years and older, and assessed as being at high risk for PONV according to the Apfel Score (score 3 or 4). The primary outcome of this study is to evaluate complete response to PONV up to 24h, comparing the efficacy of adding 50 mg oral amisulpride as a third antiemetic agent to the standard institutional protocol at the Hospital da Mulher of São Paulo (IV dexamethasone 10 mg + IV ondansetron 4 mg) for laparoscopic surgeries. Secondary outcomes will evaluate (1) nausea, (2) vomiting, (3) nausea and vomiting, (4) use of rescue treatment, (5) overall adverse events, and (6) adverse events.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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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
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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
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Hospital da Mulher
São Paulo, São Paulo, Brazil
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