Post Operative Nausea and Vomiting (PONV)Phase 2NCT06887621
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
A Phase 2 study testing Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) in people with Post Operative Nausea and Vomiting (PONV), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post Operative Nausea and Vomiting (PONV)
- What is being tested?
- Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 276 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Apr 2025to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- Encapsulated amisulpride 50 mg (matched for color, weight, smell and size), Encapsulated placebo (matched for color, weight, smell and size)
- Keywords
- Amisulpride, Postoperative Nausea and Vomiting, Laparoscopy, Gynecologic Surgical Procedures
- Medical subject headings
- Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)Drug
Amisulpride will be delivered orally 1 hour before anesthesia induction.
Encapsulated placebo (matched for color, weight, smell and size)Drug
Placebo will be delivered orally 1 hour before anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure. Receives: Drug: Encapsulated placebo (matched for color, weight, smell and size) |
| Oral Amisulpride | Experimental | Amisulpride 50 mg ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure. Receives: Drug: Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after the end of anesthesia
Secondary outcomes (8)
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.
Measured: 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.
Measured: 24 hours after the end of anesthesia
Number of participants with vomiting
Any vomiting (expulsion of gastric contents) or dry-retching.
Measured: 24 hours after the end of anesthesia
Number of participants with nausea and vomiting
Any nausea, vomiting, or dry-retching.
Measured: 24 hours after the end of anesthesia
Nausea Intensity
0 to 10 scale
Measured: 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
Measured: 24 hours after the end of anesthesia
Total number of adverse events
Any adverse event
Measured: 48 hours after ingestion of the capsule
Number of serious adverse event
Any adverse event classified as severe or life-threatening
Measured: 48 hours after ingestion of the capsule
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start10 Apr 2025
- Primary completion29 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Nausea and Vomiting (PONV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Principal investigator, amsousa, Instituto do Cancer do Estado de São Paulo
- Investigators
- Angela M Sousa, MD, MsC, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887621
- Sponsor's protocol ID
- 83804424.3.0000.0083
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06887621
- Acronym / sponsor ID
- 83804424.3.0000.0083
- Keywords
- Amisulpride, Postoperative Nausea and Vomiting, Laparoscopy, Gynecologic Surgical Procedures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 29 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Encapsulated placebo (matched for color, weight, smell and size)Placebo ● Dexamethasone 10 mg IV immediately after anesthesia induction ● Ondansetron 4 mg IV at the end of the surgical procedure. |
| Oral Amisulpride | Experimental | Drug: Encapsulated amisulpride 50 mg (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encapsulated amisulpride 50 mg (matched for color, weight, smell and size)Amisulpride will be delivered orally 1 hour before anesthesia induction. | Drug | Oral Amisulpride |
| Encapsulated placebo (matched for color, weight, smell and size)Placebo will be delivered orally 1 hour before anesthesia induction. | Drug | Placebo |
Primary outcome
Number of participants with complete response
Time frame: 24 hours after the end of anesthesia
Complete response defined as the absence of emetic episodes (nausea, vomiting or retching) and no use of antiemetic medications.
8 secondary outcomes
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
Nausea 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers. Data shared will be coded, with no PHI included.
Related trials for Post Operative Nausea and Vomiting (PONV)
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
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Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela M Sousa, MD, MsC, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Encapsulated amisulpride 50 mg (matched for color, weight, smell and size) in people with Post Operative Nausea and Vomiting (PONV), run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with complete response (time frame: 24 hours after the end of anesthesia). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.