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NCT Number: NCT06887621

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

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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Key information

Conditions

Post Operative Nausea and Vomiting (PONV) Nausea Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Nausea and Vomiting Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital da Mulher

São Paulo, Brazil

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)

Drug

Amisulpride will be delivered orally 1 hour before anesthesia induction.

Encapsulated placebo (matched for color, weight, smell and size)

Drug

Placebo will be delivered orally 1 hour before anesthesia induction.

Primary outcomes

  1. Number of participants with complete response

    Time frame: 24 hours after the end of anesthesia

    Complete response defined as the absence of emetic episodes (nausea, vomiting or retching) and no use of antiemetic medications.

Secondary outcomes

  1. Time to first violation of the criteria for complete response

    Time frame: 24 hours after the end of anesthesia

    Time in minutes from the end of anesthesia until violation of criteria for complete response, defined as the absence of emetic episodes (nausea, vomiting or retching) and no use of antiemetic medications.

  2. Number of participants with any nausea

    Time frame: 24 hours after the end of anesthesia

    Nausea (defined as unpleasant, subjective abdominal discomfort associated with the desire to vomit) measured on a 0 to 10 verbal response scale, in which 0 = no nausea at all and 10 = the worst nausea imaginable. "Any nausea" means a score ≥ 1.

  3. Number of participants with vomiting

    Time frame: 24 hours after the end of anesthesia

    Any vomiting (expulsion of gastric contents) or dry-retching.

  4. Number of participants with nausea and vomiting

    Time frame: 24 hours after the end of anesthesia

    Any nausea, vomiting, or dry-retching.

  5. PONV Intensity

    Time frame: 24 hours after the end of anesthesia

    0 to 10 scale

  6. Number of Participants Receiving Rescue Medication

    Time frame: 24 hours after the end of anesthesia

    Rescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or vomiting and/or dry-retching, or any incidental use of a drug known to have antiemetic potential

  7. Total number of adverse events

    Time frame: 48 hours after ingestion of the capsule

    Any adverse event

  8. Number of serious adverse event

    Time frame: 48 hours after ingestion of the capsule

    Any adverse event classified as severe or life-threatening

Study contacts

Contact information is provided by the study sponsor or research team.

Natanael Pietroski dos Santos, MD

CONTACT

[email protected]

+55 11 963167080

Sponsors and collaborators

Lead sponsor

Instituto do Cancer do Estado de São Paulo

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 20, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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