Using oral amisulpride to prevent nausea after gynecological surgery

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

This study is testing if taking oral amisulpride can help prevent nausea and vomiting after gynecological surgery for patients who are at high risk for these issues.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 276 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Instituto do Cancer do Estado de São Paulo (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT06887621 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of adding oral amisulpride to standard dual prophylaxis for preventing postoperative nausea and vomiting (PONV) in patients undergoing gynecological surgery. The study involves a quadruple-blind design, where participants at high risk for PONV, as determined by the Apfel Score, will receive either amisulpride or a placebo. The primary outcome is to assess the complete response to PONV within 24 hours post-surgery. This approach aims to provide a more affordable and less painful alternative to intravenous amisulpride, which has limitations in terms of availability and side effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older undergoing laparoscopic hysterectomy for benign conditions and assessed as high risk for PONV.

Not a fit: Patients with cognitive impairments, certain medical conditions, or those currently using antipsychotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a more effective and convenient option for preventing postoperative nausea and vomiting in high-risk patients.

How similar studies have performed: While the use of amisulpride for PONV is novel, other studies have shown success with similar approaches in managing postoperative nausea.

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 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

Where this trial is running

São Paulo, São Paulo

• Hospital da Mulher — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Principal investigator: Angela M Sousa, MD, MsC, PhD — University of Sao Paulo
• Study coordinator: Natanael Pietroski dos Santos, MD

Conditions Post Operative Nausea and Vomiting; Amisulpride; Postoperative Nausea and Vomiting; Laparoscopy; Gynecologic Surgical Procedures