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Tests treatment safety and results for Post Operative Nausea and Vomiting (PONV)
Official title Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery
ClinicalTrials.gov ID: NCT06887621
What this study is testing
What is Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)?
Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post operative nausea and vomiting (ponv).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- 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.
You likely can't join if
- 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...
- Inability to swallow medications.
- Current use of typical or atypical antipsychotic medications.
- Gestation or lactation.
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.