[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-operative-nausea-and-vomiting-ponv\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-operative-nausea-and-vomiting-ponv":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100584306","phase-2-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-100584306",false,"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","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","Inclusion Criteria:\n\n* Laparoscopic hysterectomy to treat benign conditions.\n* High risk for PONV according to the Apfel Score: scores 3 or 4.\n* American Society of Anesthesiology (ASA) physical status: 1 or 2.\n\nExclusion Criteria:\n\n* Cognitive or psychiatric conditions impairing consent or compliance.\n* Incapability of using the mobile app MyCapp for data collection.\n* 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.\n* Inability to swallow medications.\n* Current use of typical or atypical antipsychotic medications.\n* Gestation or lactation.\n* Clinically significant cardiac arrhythmia or long QT syndrome documented.\n* Hypokalemia (K+ \\\u003C 3.5 mmol\u002FL)\n* Prolactin-dependent tumors.\n* Pheochromocytoma.\n* Parkinson's disease.\n* Nausea or vomiting in the 24 hours before surgery.\n* Therapeutic use of antiemetics, including corticosteroids.\n* Emetogenic oncological therapy (above 10% probability of causing vomiting) in the 2 weeks before surgery.\n* Persistent pre-operative hypotension on the day of surgery, defined as systolic blood pressure \\\u003C 100 mmHg on at least 2 consecutive measurements.\n* Mechanical ventilation plan or need for a naso\u002Forogastric tube after surgery.\n* Intestinal endometriosis","FEMALE","18 Years",{"count":19,"type":20},276,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","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.",[26],"Post Operative Nausea and Vomiting (PONV)",[28,29,30,31],"Amisulpride","Postoperative Nausea and Vomiting","Laparoscopy","Gynecologic Surgical Procedures","RECRUITING","2025-04-10",{"date":35,"type":36},"2025-04-13","ACTUAL",{"date":33,"type":36},{"date":39,"type":20},"2027-03-31",{"name":41,"class":42},"Instituto do Cancer do Estado de São Paulo","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100557888","phase-3-efficacy-and-safety-study-of-aprepitant-injection-for-prevention-of-post-operative-nausea-and-vomiting-100557888","NCT06543966","Efficacy and Safety Study of Aprepitant Injection for Prevention of Post-operative Nausea and Vomiting","A Randomized, Double-blind, Placebo-controlled, Multi-center Phase III Study to Evaluate the Efficacy and Safety of Aprepitant Injection in the Prevention of Post-operative Nausea and Vomiting","Inclusion Criteria:\n\nAge ≥18 and ≤75 years old; 18 \\\u003C BMI≤30kg\u002Fm\\^2, body weight ≥45kg; laparoscopic gynecologic or abdominal surgery under general anesthesia that was expected to last at least 1 hour.\n\nexpected or agreed to stay in the hospital for 24 hours or more after surgery;\n\nExclusion Criteria:\n\ndiagnostic surgery; scheduled for postoperative transfer to an intensive care unit; requiring placement of a nasogastric or orogastric tube after surgery; Post-operative vomiting may pose significant risk;","ALL","75 Years",{"count":54,"type":20},486,[56],"PHASE3","A randomized, double-blind, placebo-controlled, multi-center phase III study to compare the efficacy and safety of aprepitant injection and placebo in the prevention of post-operative nausea and vomiting (PONV).,",[59],"Post-operative Nausea and Vomiting (PONV)","NOT_YET_RECRUITING","2024-08-05",{"date":63,"type":36},"2024-08-09",{"date":65,"type":20},"2024-10-28",{"date":67,"type":20},"2026-03-28",{"name":69,"class":70},"CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.","INDUSTRY","Post-Operative Nausea and Vomiting (PONV)"]