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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Encapsulated amisulpride 50 mg (matched for color, weight, smell and size), Encapsulated placebo (matched for color, weight, smell and size).
- Who it may be relevant to
- Registry conditions: Post Operative Nausea and Vomiting (PONV). Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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.
Interventions
- Drug Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)
Amisulpride will be delivered orally 1 hour before anesthesia induction. - Drug Encapsulated placebo (matched for color, weight, smell and size)
Placebo will be delivered orally 1 hour before anesthesia induction.
Primary outcome measures
- Number of participants with complete response [Time frame: 24 hours after the end of anesthesia]
Secondary outcome measures (8)
- Time to first violation of the criteria for complete response [Time frame: 24 hours after the end of anesthesia]
- Number of participants with any nausea [Time frame: 24 hours after the end of anesthesia]
- Number of participants with vomiting [Time frame: 24 hours after the end of anesthesia]
- Number of participants with nausea and vomiting [Time frame: 24 hours after the end of anesthesia]
- PONV Intensity [Time frame: 24 hours after the end of anesthesia]
- Number of Participants Receiving Rescue Medication [Time frame: 24 hours after the end of anesthesia]
- Total number of adverse events [Time frame: 48 hours after ingestion of the capsule]
- Number of serious adverse event [Time frame: 48 hours after ingestion of the capsule]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Brazil · 1 center
- Hospital da Mulher — São Paulo
Identifiers
NCT: NCT06887621 · 83804424.3.0000.0083