PONVAmisulprideNCT07554040
Amisulpride for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
An observational study of PONV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
This study aims to focus on patients undergoing gynecological laparoscopic surgery and further evaluate the role of amisulpride in preventing postoperative nausea and vomiting in these patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- PONV
- What is being tested?
- Tropisetron
- How many people
- 526 participants
- Where
- No sites listed yet
- Study dates
- 10 May 2026to 10 Dec 2026
- Phase
- Observational
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Agree and sign the informed consent form
Who may be able to join
- 1. 18<BMI≤30kg/m2 2. Patients scheduled to undergo gynecological laparoscopic surgery (e.g., ovary, fallopian tube, uterus, and gynecological tumors, etc., with an expected surgery duration of ≤3 hours)
Who cannot join
- 1. ASA class IV or above 2. Long-term use of opioid drugs or non-steroidal anti-inflammatory drugs 3. Undergoing radiotherapy and chemotherapy 4.Allergic to the medication used 5.Pregnant or breastfeeding women 6.Previously existing vestibular disorders or chronic dizziness, easily nauseous 7.Recent use of antiemetic drugs or prophylactic antiemetic regimen (within 7 days before surgery) 8.Presence of neurological or psychiatric disorders, or cognitive impairment
About this study
Official title: Amisulpride Used for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery: a Prospective Observational Cohort Study
This study aims to focus on patients undergoing gynecological laparoscopic surgery and further evaluate the role of amisulpride in preventing postoperative nausea and vomiting in these patients.
Read the detailed description
Gynecological laparoscopic surgery patients usually combine multiple high-risk factors such as being 'female,' undergoing 'laparoscopic procedures,' and having 'gynecological surgery,' making the prevention and treatment of PONV a key focus and challenge.Among patients undergoing gynecological laparoscopic surgery, there is still a lack of targeted clinical data support.
- Conditions
- PONV
- Being tested
- Tropisetron
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TropisetronDrug
Also called Amisulpride
and receive tropisetron (2mg) as a postoperative prophylactic antiemetic
| Study group | Role | What they receive |
|---|---|---|
| Amisulpride | Receiving amisulpride (5mg) as postoperative prophylactic antiemetic drugs Receives: Drug: Tropisetron | |
| Tropisetron | receiving tropisetron (2mg) as postoperative prophylactic antiemetic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission (CR) rate within 24 hours postoperatively
The proportion of patients who, within 24 hours after surgery, experience neither vomiting episodes (vomiting/retching) nor require rescue antiemetic medication
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start10 May 2026 (estimated)
- Primary completion10 Sep 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PONVStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 526 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554040
- Sponsor's protocol ID
- 20260539
- Acronym
- Amisulpride
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amisulpride Used for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07554040
- Acronym / sponsor ID
- Amisulpride / 20260539
- Conditions
- PONV
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 526 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 May 2026 (estimated)
- Primary completion
- 10 Sep 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 28 Apr 2026 (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.
This study aims to focus on patients undergoing gynecological laparoscopic surgery and further evaluate the role of amisulpride in preventing postoperative nausea and vomiting in these patients.
Detailed description
Gynecological laparoscopic surgery patients usually combine multiple high-risk factors such as being 'female,' undergoing 'laparoscopic procedures,' and having 'gynecological surgery,' making the prevention and treatment of PONV a key focus and challenge.Among patients undergoing gynecological laparoscopic surgery, there is still a lack of targeted clinical data support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Amisulpride | – | Drug: TropisetronReceiving amisulpride (5mg) as postoperative prophylactic antiemetic drugs |
| Tropisetron | – | –receiving tropisetron (2mg) as postoperative prophylactic antiemetic drugs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Agree and sign the informed consent form
Key inclusion criteria (1 listed)
- 1. 18<BMI≤30kg/m2 2. Patients scheduled to undergo gynecological laparoscopic surgery (e.g., ovary, fallopian tube, uterus, and gynecological tumors, etc., with an expected surgery duration of ≤3 hours)
Key exclusion criteria (1 listed)
- 1. ASA class IV or above 2. Long-term use of opioid drugs or non-steroidal anti-inflammatory drugs 3. Undergoing radiotherapy and chemotherapy 4.Allergic to the medication used 5.Pregnant or breastfeeding women 6.Previously existing vestibular disorders or chronic dizziness, easily nauseous 7.Recent use of antiemetic drugs or prophylactic antiemetic regimen (within 7 days before surgery) 8.Presence of neurological or psychiatric disorders, or cognitive impairment
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 |
|---|---|---|
| TropisetronAlso: Amisulprideand receive tropisetron (2mg) as a postoperative prophylactic antiemetic | Drug | Amisulpride |
Primary outcome
Complete remission (CR) rate within 24 hours postoperatively
Time frame: 1 day
The proportion of patients who, within 24 hours after surgery, experience neither vomiting episodes (vomiting/retching) nor require rescue antiemetic medication
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 28 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
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Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
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Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of PONV, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Complete remission (CR) rate within 24 hours postoperatively (time frame: 1 day). 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 28 Apr 2026.