About this trial
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.
Eligibility criteria
Qualifiers
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);
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HRS5580 for injection combined with palonosetron hydrochloride;
- HRS5580 for injection combined with palonosetron hydrochloride
- HRS5580 for injection combined with palonosetron hydrochloride
- HRS5580 for injection blank preparation combined with palonosetron hydrochloride