Amisulpride for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery (Amisulpride)

April 21, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Agree and sign the informed consent form

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Amisulpride
Receiving amisulpride (5mg) as postoperative prophylactic antiemetic drugs
Drug: Tropisetron
and receive tropisetron (2mg) as a postoperative prophylactic antiemetic
Other Names:
  • Amisulpride
Tropisetron
receiving tropisetron (2mg) as postoperative prophylactic antiemetic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 10, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20260539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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