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
Recruiting
Phase 2
Interventional Study
Post Operative Nausea and Vomiting (PONV)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 276 (estimated)
- Sponsor
- Instituto do Cancer do Estado de São Paulo · Other
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About This Trial
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 thes…
Trial Locations
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Eligibility Criteria
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 complian…
Contacts