a clinical trial evaluating the efficacy and safety of hsk21542 in ponv

Conditions: Postoperative Nausea and Vomiting

Summary: this is a multicenter, randomized, double-blind, placebo-controlled dose-finding study. about 200 subjects undergoing elective laparoscopic abdominal or gynecological surgery are planned to be enrolled and randomized into four groups by a ratio of 1:1:1:1.


Eligibility criteria:
inclusion criteria: 1. age ≥18 and ≤75 years old, male or female; 2. the american society of anesthesiologists (asa) class i-iii; 3. 18 kg/m2 ≤ bmi ≤ 40 kg/m2; 4. hospitalized subjects scheduled to undergo elective laparoscopic abdominal or gynecological surgery under general anesthesia for an expected anesthetic time of ≥ 1 h; 5. subjects with intermediate or high risk (score ≥ 2 points) experiencing ponv judged by the investigator using the apfel simplified risk score; 6. subjects who agree to participate in the trial and voluntarily sign the informed consent form (icf); exclusion criteria: prior and concomitant diseases 1. history or evidence of any of the following diseases prior to screening: 1. respiratory diseases: severe chronic obstructive pulmonary disease, acute exacerbation of chronic obstructive pulmonary disease, severe airway stenosis, large pharyngolaryngeal mass, (broncho) tracheoesophageal fistula or airway tear, and serious respiratory tract infection within 2 weeks prior to screening; 2. central nervous system disorders: subjects with epilepsy, parkinson's disease, or other central nervous system diseases causing nausea and vomiting, such as craniocerebral injury, intracranial space-occupying lesions, intracranial aneurysms, etc.; 3. cardiovascular diseases: subjects with uncontrolled hypertension \[systolic blood pressure (sbp) ≥170 mmhg and/or diastolic blood pressure (dbp) ≥105 mmhg without treatment with antihypertensive medication, or sbp ≥160 mmhg and/or dbp ≥100 mmhg after treatment with antihypertensive medications\], serious cardiac insufficiency ( the new york heart association \[nyha\] grade iii-iv), unstable angina pectoris, acute myocardial infarction, severe arrhythmia, history of tachycardia/bradycardia requiring medical treatment, grade ii-iii atrioventricular block (excluding pacemaker use) within 6 months prior to screenin; 4. digestive disorders: subjects with intestinal obstruction or other digestive diseases that may cause nausea and vomiting as judged by the investigator; 5. patients with a confirmed diagnosis of vestibular function disorder, excluding travel sickness (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.); 6. subjects with a history of significant and chronic dizziness. prior and concomitant medications 2. any of the following medications or treatments have been used at screening: 1. subjects who have received antiemetics/medications with antiemetic effects within 24 h before the start of surgery or who have used antiemetics/drugs with antiemetic effects before the start of surgery for no more than 5 half-lives (calculated as the longest time); 2. subjects with neoplasm malignant treated with chemotherapy within 4 weeks prior to screening; laboratory and other tests 3. laboratory test indicators at screening meet the following criteria: 1. white blood cell count \< 3.0 × 109/l; 2. platelet count \< 80 × 109/l; 3. hemoglobin\< 70 g/l; 4. prolongation of prothrombin time (pt) exceeding the upper limit of normal for 3 seconds; 5. prolongation of activated partial thromboplastin time (aptt) exceeding the upper limit of normal for 10 seconds; 6. alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \> 3 × uln; 7. total bilirubin \> 2 × uln; 8. blood creatinine \> 2 × uln; 9. fasting serum glucose≥ 11.1 mmol/l; other conditions 4. subjects anticipated to require continued endotracheal intubation after the end of surgery; 5. subjects anticipated to require the insertion of nasal or oral gastric tubes after the end of surgery; 6. subjects with a history of serious drug allergies or those allergic to the investigational drugs specified in the protocol; 7. subjects with a history of drug abuse, drug addiction, or alcoholism within 3 months prior to screening, where alcoholism is defined as consuming \> 2 units of alcohol on average daily (1 unit = 360 ml of beer with 5% alcohol, 45 ml of liquor with 40% alcohol or 150 ml of wine); 8. subjects with nausea, retching, or vomiting within 24 h prior to induction of anesthesia (except for those caused by bowel preparation); 9. subjects who have participated in any investigational trial (defined as receiving investigational drug or placebo) within 3 months prior to screening; 10. female subjects who are pregnant or breastfeeding; female or male subjects of child-bearing potential are unwilling to use contraception throughout the entire study period and for 3 months after the study completion; 11. subjects judged by the investigator to be unsuitable for participating in this clinical trial for any other factors.