Postoperative nausea and vomiting
Conditions
Interventions
Amisulpride group:Administration of intravenous 2ml Amisulpride
placebo group:Administration of intravenous 2ml normal saline
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 18= age =75 years old, regardless of gender; 2. Body mass index (BMI) between 18.0 and 30.0kg/m2 (including cut-off value); 3. Subjects were classified as grade I-III according to the American Society of Anesthesiologists (ASA) classification criteria; 4. Hospitalized subjects who plan to undergo abdominal surgery (including gynecological surgery) under general anesthesia (propofol/cyclopropofol anesthesia induction is allowed, propofol/cyclopropofol anesthesia maintenance is prohibited), and the expected maintenance time of inhalation anesthesia is at least 1 hour; 5. Subjects with moderate or high risk of postoperative nausea and vomiting (PONV) (score =2) were judged by the researchers according to the simplified risk score of Apfel; 6. The subjects were able to understand the procedures and methods of the clinical trial, and voluntarily participated in the trial with full informed consent signed by the subjects themselves or their legal guardians; 7. Be able to read, understand and complete the self-assessment scale of nausea degree and the related evaluation scale of efficacy.
Exclusion criteria
Exclusion criteria: 1. Subjects who plan to receive only local anesthesia such as topical anesthesia, local infiltration anesthesia, regional block, nerve block, and spinal anesthesia (intrathecal or epidural block); 2. Allergic or idiopathic reactions to amisulpride injection or any excipients or any components of the drugs used in this trial; 3. Patients with any of the following clinically serious illnesses or current serious illnesses that would affect the trial as judged by the investigator: 1) Respiratory disease: subjects with severe respiratory disease requiring ICU transfer for respiratory support after surgery; 2) Central nervous system diseases: subjects with epilepsy, Parkinson's disease, or other central nervous system diseases causing nausea and vomiting such as craniocerebral trauma, intracranial mass, intracranial aneurysm, etc.; 3) Cardiovascular disease: severe heart failure (New York Heart Association class III-IV), unstable angina, acute myocardial infarction, or refractory hypertension (poorly controlled with three or more antihypertensive drugs) within 6 months before screening: Systolic blood pressure =160mmHg or diastolic blood pressure =100mmHg) and other heart diseases considered by the investigators to be clinically significant; 4) Digestive diseases: subjects with intestinal obstruction or other digestive diseases causing nausea and vomiting; 5) clinically significant arrhythmia subjects, such as prolonged QTcF interval (male =450 ms, female =460 ms), severe bradycardia (heart rate =45 beats/min), severe II or III degree atrioventricular block (excluding subjects with pacemakers), atrial fibrillation; 6) subjects with a history of congenital long QT syndrome or family history of QT syndrome; 7) a definite diagnosis of vestibular diseases (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.); 8) subjects with a history of significant, chronic dizziness; 9) subjects with prolactin-dependent tumors (such as pituitary prolactinoma or breast cancer), or pheochromocytoma. 4. Laboratory test results during the screening period meet the following criteria: 1) hemoglobin (Hb) =90g/L; 2) platelet count (PLT) =50×109/L; 3) clinically significant hypokalemia: serum potassium 1.5 times the upper limit of normal value; 5) Renal function: creatinine > 1.2 times the upper limit of normal; 6) Prothrombin time (PT) > upper limit of normal +3s, or activated partial thrombin time (APTT) > upper limit of normal +10s. 5. subjects with a history of substance abuse or substance abuse within 6 months before randomization; 6. Subjects who received chemotherapy or combined malignant tumors within 4 weeks before screening; 7. Subjects who have received or are receiving the active ingredient of amisulpride injection within 2 weeks before randomization; 8. subjects who were receiving levodopa or another target drug (domperidone, zolsulpiride, metoclopramide, chlorpromazine, clozapine, etc.) within 2 weeks before randomization; 9. subjects who received a drug to induce torsade de pointes within the five half-life periods before randomization; 10. Subjects who received antiemetic drugs or drugs with potential antiemetic efficacy within the 5 half-lives before randomization; 11. Subjects who experienced nausea, retching, or vomiting within 24 hours before random
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| blood pressure;Heart rate, pulse;breathe; | — |
Primary
| Measure | Time frame |
|---|---|
| Nausea rating scale; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed