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

N/ANot Yet RecruitingNCT07554040

Second Affiliated Hospital, Zhejiang University, School of Medicine526 enrolled

Overview

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.

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

526

Conditions

PONV

Interventions

TropisetronDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 day

Data from ClinicalTrials.gov

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