Preventing of Postoperative Nausea and Vomiting in Adults
Conditions
Brief summary
The study is being conducted to evaluate the efficacy, and safety of HRS5580 for preventing of postoperative nausea and vomiting in adults. To explore the reasonable dosage of HRS5580 for postoperative nausea and vomiting.
Interventions
DRUGHRS5580
HRS5580; low dose
DRUGOndansetron
Ondansetron
DRUGblank preparation
blank preparation.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Plan to undergo elective surgery under general anesthesia； 3. ≥18 years old 4. Meet the weight standard 5. Conform to the ASA Physical Status Classification 6. Expected postoperative hospital stay ≥72 hours 7. PONV risk factors ≥3
Exclusion criteria
1. Subjects with vomiting and/or retching and nausea occurred before surgery 2. Subjects with a history of vestibular disease, central nervous system and other system diseases 3. Subjects with a previous history of chronic nausea or vomiting/retching 4. Subjects with a history of myocardial infarction or unstable angina pectoris 5. Subjects with atrioventricular block or cardiac insufficiency 6. Subjects with a history of ischemic stroke or transient ischemic attack 7. Subjects with poor blood pressure control after medication 8. Abnormal electrocardiogram 9. Abnormal values in the laboratory 10. Allergic to a drug ingredient or component 11. Received treatment with potential antiemetic effects before starting the investigational product 12. Subjects who received chemotherapy prior to surgery 13. Use of drugs that affect the antiemetic effect, and the time between the last use of the test drug and the start of the time is less than 5 half-lives 14. Plan to receive local anesthesia only or total intravenous anesthesia only 15. Subjects who are expected to require an in-situ nasogastric tube or orogastric tube after completion of surgery 16. Subjects expected to be transferred to the ICU at the end of surgery 17. Pregnant or nursing women 18. No birth control during the specified period of time 19. Participated in clinical trials of other drugs (received experimental drugs) 20. The inestigators determined that other conditions were inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No vomiting rate within 72 hours after extubation | at 72 hours after extubation |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate (defined as the proportion of subjects without vomiting and receiving no rescue therapy) at 24, 48, 72, 96, and 120 hours after extubation | at24, 48, 72, 96, and 120 hours after extubation |
| No vomiting at 24, 48, 96, and 120 hours after extubation, | at 24, 48, 96, and 120 hours after extubation |
| Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation | at 24, 48, 72, 96, and 120 hours after extubation |
| Proportion of participants not receiving rescue medication within 24, 48, 72, 96, and 120 hours of extubation | at 24, 48, 72, 96, and 120 hours of extubation |
Countries
China
Outcome results
None listed