Status:
RECRUITING
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
Lead Sponsor:
Instituto do Cancer do Estado de São Paulo
Collaborating Sponsors:
University Medical Center Groningen
Conditions:
Post Operative Nausea and Vomiting (PONV)
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
276 Patients enrolled
Trial Details
Trial ID
NCT06887621
Start Date
April 10 2025
End Date
March 31 2027
Last Update
April 13 2025
Active Locations (1)
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1
Hospital da Mulher
São Paulo, São Paulo, Brazil