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.
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.
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.
Parallel
Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)
DrugAmisulpride will be delivered orally 1 hour before anesthesia induction.
Encapsulated placebo (matched for color, weight, smell and size)
DrugPlacebo will be delivered orally 1 hour before anesthesia induction.
Number of participants with complete response
Complete response defined as the absence of emetic episodes (nausea, vomiting or retching) and no use of antiemetic medications.
Time to first violation of the criteria for complete response
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.
Number of participants with any nausea
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.
Number of participants with vomiting
Any vomiting (expulsion of gastric contents) or dry-retching.
Number of participants with nausea and vomiting
Any nausea, vomiting, or dry-retching.
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Instituto do Cancer do Estado de São Paulo
Lead sponsor
University Medical Center Groningen
Collaborator
