NCT07554040

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started May 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

May 10, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2026

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 21, 2026

Last Update Submit

April 21, 2026

Conditions

PONV

Outcome Measures

Primary Outcomes (1)

  • 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

    1 day

Study Arms (2)

Amisulpride

Receiving amisulpride (5mg) as postoperative prophylactic antiemetic drugs

Drug: Tropisetron

Tropisetron

receiving tropisetron (2mg) as postoperative prophylactic antiemetic drugs

Interventions

TropisetronDRUG

and receive tropisetron (2mg) as a postoperative prophylactic antiemetic

Also known as: Amisulpride
Amisulpride

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Agree and sign the informed consent form

You may qualify if:

  • \. 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)

You may not qualify if:

  • \. 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

TropisetronAmisulpride

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2026

First Posted

April 28, 2026

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 10, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04