The study is being conducted to evaluate the efficacy of HRS5580 for injection combined with palonosetron hydrochloride in the prevention of postoperative nausea and vomiting, and to explore the effective dose of HRS5580 for injection combined with palonosetron hydrochloride for the prevention of postoperative nausea and vomiting.
Voluntarily sign the informed consent form prior to the start of any trial-related activities, fully understand the purpose and significance of the study, and voluntarily comply with the trial procedures;
2、Scheduled to undergo elective surgery under general anesthesia with an expected surgical duration of ≥ 2 hours (surgery types include gynecological surgery, hepatobiliary surgery, intestinal surgery, urological surgery, etc.);
Aged ≥ 18 years;
Body Mass Index (BMI) between 18 kg/m² and 28 kg/m² (inclusive);
Patients with a history of vestibular disorders (including but not limited to: peripheral vestibular syndrome, central vestibular syndrome, etc.) or dizziness (excluding history of motion sickness), or a history of central nervous system disorders that may cause nausea and vomiting;
History of chronic nausea or vomiting/retching;
History of new-onset myocardial infarction or unstable angina pectoris within 6 months prior to screening, or history of severe cardiac arrhythmias such as second-degree or higher atrioventricular block, or history of New York Heart Association (NYHA) Functional Classification Class II or higher;
Any other medical condition that, in the investigator's judgment, may confound the assessment of postoperative nausea and/or vomiting.
Parallel
HRS5580 for injection combined with palonosetron hydrochloride;
DrugHRS5580 for injection combined with palonosetron hydrochloride; low dose
HRS5580 for injection combined with palonosetron hydrochloride
DrugHRS5580 for injection combined with palonosetron hydrochloride; high dose
HRS5580 for injection blank preparation combined with palonosetron hydrochloride
DrugHRS5580 for injection blank preparation combined with palonosetron hydrochloride
Complete response rate within 72 hours after extubation (defined as the proportion of participants with no vomiting and no use of rescue therapy)
Complete response rate within 24hours, 48hours, 24-48hours, 24-72hours, 96hours, and 120hours after extubation
Vomiting-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
Nausea-free rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
PONV （postoperative nausea and vomiting）rate within 24hours, 48hours, 24-48hours, 72hours, 24-72hours, 96hours, and 120hours after extubation
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