None
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Guangxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years old (including 18 and 70, no gender restriction) 2.18 kg/m^2 45 kg 3.Planned elective abdominal or gynecological surgery under general anesthesia, expected to maintain inhalation anesthesia for more than 1 hour 4. American Society of Anesthesiologists (ASA) Classification I and II 5. Using the Apfel simplified risk score, patients with at least 2 risk factors (Apfel score >=2) 6. Subjects who are able to read, understand, and complete the Visual Analog Scale (VAS) and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Patients planning to undergo outpatient/day surgery 2. Patients planning to receive organ transplant surgery 3. Patients who may develop respiratory dysfunction, clinically significant hypotension, bradycardia, or other abnormalities that significantly increase clinical trial risks during or after surgery 4. Patients for whom postoperative vomiting may pose a significant danger 5. Patients expected to require an in-situ nasogastric or orogastric tube after surgery 6. Patients allergic to the active ingredients or any excipients of amisulpride injection/ondansetron injection, or allergic to medications during or after surgery 7. Patients with abnormal liver function (ALT or AST > 2 times the upper limit of normal, ALP > 1.5 times the upper limit of normal, total bilirubin > 1.2 times the upper limit of normal); patients with abnormal kidney function (Cr > upper limit of normal and/or eGFR < 30 mL/min/1.73m^2) 8. Patients with a history of vestibular disease or dizziness, or a history of gastrointestinal, central nervous system, or other systemic diseases that may cause nausea and vomiting 9. Patients with severe cardiovascular disease at screening or before randomization 10. Pregnant or breastfeeding women, women planning pregnancy, or women of childbearing potential not using appropriate contraception 11. Patients with known or suspected alcohol abuse or drug abuse within 6 months before screening 12. Any other condition that the investigator considers inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with complete response (CR) of postoperative nausea and vomiting (PONV); | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects without nausea episodes within 24 hours post-surgery;Proportion of subjects experiencing significant nausea within 24 hours post-surgery;Proportion of subjects with no vomiting episodes within 24 hours after surgery;Proportion of subjects with complete control (CC) of PONV within 24 hours after surgery;Overall response rate: the proportion of subjects with no vomiting episodes (vomiting/retching) within 24 hours postoperatively, no nausea (VAS nausea score < 10 mm), and who did not use rescue treatment;Proportion of subjects who received rescue treatment within 24 hours post-surgery;Time of treatment failure within 24 hours post-surgery; | — |
Countries
China
Contacts
Public ContactQiufeng Wei
The First Affiliated Hospital of Guangxi Medical University
Outcome results
None listed