Phase
Condition
Stomach Discomfort
Vomiting
Lactose Intolerance
Treatment
Encapsulated placebo (matched for color, weight, smell and size)
Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)
Clinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
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
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 2weeks before surgery.
Persistent pre-operative hypotension on the day of surgery, defined as systolicblood pressure < 100 mmHg on at least 2 consecutive measurements.
Mechanical ventilation plan or need for a naso/orogastric tube after surgery.
Intestinal endometriosis
Study Design
Connect with a study center
Hospital da Mulher
São Paulo, SP
BrazilActive - Recruiting
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