A Phase 2 interventional study of Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) and Encapsulated placebo (matched for color, weight, smell and size) in Post Operative Nausea and Vomiting (PONV), sponsored by Instituto do Cancer do Estado de São Paulo. Active, not recruiting at 1 site in Brazil. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-09.
Sponsored by Instituto do Cancer do Estado de São Paulo · Phase 2, Interventional, and Prevention
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.
1,100 studies on the registry are indexed under Vomiting; 134 are open to participants now.
This study's planned enrollment of 276 is above the median of 107 across 935 interventional studies indexed under Vomiting.
Browse Vomiting studies →Instituto do Cancer do Estado de São Paulo is the lead sponsor of 90 studies on the registry; 23 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Placebo ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure.
Drug: Encapsulated placebo (matched for color, weight, smell and size)
Amisulpride 50 mg ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure.
Drug: Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)
Amisulpride will be delivered orally 1 hour before anesthesia induction.
Placebo 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 frame: 24 hours after the end of anesthesia
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.
Time frame: 24 hours after the end of anesthesia
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.
Time frame: 24 hours after the end of anesthesia
Number of participants with vomiting
Any vomiting (expulsion of gastric contents) or dry-retching.
Time frame: 24 hours after the end of anesthesia
Number of participants with nausea and vomiting
Any nausea, vomiting, or dry-retching.
Time frame: 24 hours after the end of anesthesia
Nausea Intensity
0 to 10 scale
Time frame: 24 hours after the end of anesthesia
Number of Participants Receiving Rescue Medication
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
Time frame: 24 hours after the end of anesthesia
Total number of adverse events
Any adverse event
Time frame: 48 hours after ingestion of the capsule
Number of serious adverse event
Any adverse event classified as severe or life-threatening
Time frame: 48 hours after ingestion of the capsule
Plan to share: Yes — Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Instituto do Cancer do Estado de São Paulo