A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults
NCT ID: NCT06475846
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
235 participants
INTERVENTIONAL
2024-06-25
2024-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Treatment group A: HRS5580
HRS5580
HRS5580; low dose
Treatment group B: HRS5580
HRS5580
HRS5580; middle dose
Treatment group C: HRS5580
HRS5580
HRS5580; middle dose
Treatment group D: Ondansetron
Ondansetron
Ondansetron
Treatment group E: blank preparation.
blank preparation
blank preparation.
Interventions
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HRS5580
HRS5580; low dose
HRS5580
HRS5580; middle dose
HRS5580
HRS5580; middle dose
Ondansetron
Ondansetron
blank preparation
blank preparation.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Fujian Shengdi Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Third Xiangya Hospital of Central South University
Changsha, Hu'nan, China
Countries
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Other Identifiers
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HRS5580-201
Identifier Type: -
Identifier Source: org_study_id
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