Postoperative nausea and vomiting,PONV
Conditions
Interventions
Sponsors
Shandong Provincial Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily agree to participate in this study and provide written informed consent; 2. Aged >=18 years; 3. Scheduled for elective inpatient surgery under general anesthesia, with an expected duration of surgery >1 hour; 4. American Society of Anesthesiologists (ASA) Physical Status Classification of I–III; 5. Judged by the investigator as requiring PONV prophylaxis with Amisulpride Injection (Oukezhi®).
Exclusion criteria
Exclusion criteria: 1. Patients scheduled for emergency surgery, planned day surgery, or purely diagnostic procedures; 2. Patients planned for transfer to the ICU postoperatively or requiring in situ nasogastric or orogastric tubes after surgery; 3. Patients with prolonged QTc interval on the most recent preoperative ECG (>=450 ms for males, >=460 ms for females) accompanied by other risk factors for torsades de pointes (especially ventricular arrhythmia, atrial fibrillation, myocardial infarction due to coronary artery spasm) or other clinically significant abnormal arrhythmias; 4. Patients with abnormal hepatic or renal function on the most recent preoperative laboratory tests: ALT and/or AST >=2.5×ULN, bilirubin >=1.5×ULN, or creatinine >=1.5×ULN; 5. Patients who received amisulpride injection or its active ingredient within one week prior to surgery; 6. Patients with known hypersensitivity to amisulpride injection, its active ingredient, excipients, or auxiliary materials (citric acid hydrate, trisodium citrate hydrate, sodium chloride, hydrochloric acid, and sodium hydroxide); 7. Patients with a confirmed diagnosis of vestibular disorders (including but not limited to peripheral or central vestibular syndromes) or persistent chronic dizziness due to clear underlying gastrointestinal or central nervous system diseases; 8. Patients with known prolactin-dependent tumors (e.g., pituitary prolactinoma or breast cancer) or pheochromocytoma; 9. Women who are pregnant or breastfeeding, patients planning pregnancy during the study period, or those unwilling to use effective contraception; 10. Patients deemed by the investigator to have any medical or ethical reason that makes them unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a Complete Response (CR), defined as no vomiting (including retching/emesis) and no use of rescue antiemetic medication from the end of surgery up to 24 hours postope; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects who did not experience nausea (VAS4 points) within 24 hours after surgery;Proportion of subjects who vomited within 24 hours after surgery; | — |
Countries
China
Contacts
Public ContactWang Yuelan
Shandong Provincial Hospital
Outcome results
None listed