New drug combo aims to stop Post-Surgery nausea in its tracks
NCT ID NCT07709897
First seen Jul 17, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests an experimental drug called HRS5580, given together with a standard anti-nausea medication (palonosetron), to prevent nausea and vomiting after surgery. About 260 adults undergoing planned surgeries lasting at least 2 hours will receive one of three doses of HRS5580 or a placebo, alongside palonosetron. The main goal is to see if the combination helps patients avoid vomiting or needing rescue medication for up to 72 hours after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental drug called HRS5580 combined with palonosetron hydrochloride
- What this could lead to
- If successful, this could provide a more effective option for preventing nausea and vomiting after surgery, reducing patient discomfort and complications.
- What could go wrong
- This is an early phase 2 trial with a small number of participants, so results may not confirm effectiveness or safety. The best dose is still being explored.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 260 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. 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. 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.); 3. Aged ≥ 18 years; 4. Body Mass Index (BMI) between 18 kg/m² and 28 kg/m² (inclusive); 5. American Society of Anesthesiologists (ASA) Physical Status Classification I or II; 6. Expected postoperative hospital stay ≥ 72 hours; 7. Presence of ≥ 3 risk factors for PONV (female, history of PONV or motion sickness, non-smoker, postoperative opioid use); 8. Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and must not be breastfeeding; female participants of childbearing potential must use highly effective contraceptive measures (see Appendix 13.1.2) from 30 days prior to the screening period until 6 months after the last dose, and have no plans for egg donation or pregnancy; male participants with a female partner of childbearing potential must use highly effective contraceptive measures from the time of signing the informed consent form until 6 months after the last dose. Exclusion Criteria: 1. 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; 2. History of chronic nausea or vomiting/retching; 3. 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; 4. Any other medical condition that, in the investigator's judgment, may confound the assessment of postoperative nausea and/or vomiting. 5. Random blood glucose \> 11.1 mmol/L during the screening period; 6. Prolonged QTc interval during the screening period: \> 450 ms in males, \> 470 ms in females; 7. Systolic blood pressure ≥ 160 mmHg or \< 90 mmHg, and/or diastolic blood pressure ≥ 100 mmHg or \< 60 mmHg from the time of signing the ICF to before entering the operating room, which is considered clinically significant by the investigator; 8. Abnormal liver function during the screening period: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or gamma-glutamyl transferase (GGT) ≥ 3.0 × ULN and/or total bilirubin (TBIL) ≥ 1.5 × ULN; 9. Abnormal renal function during the screening period: serum creatinine (Cr) ≥ 1.5 × ULN and/or participants undergoing dialysis; 10. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody, or human immunodeficiency virus (HIV) antibody during the screening period; 11. Known allergy or contraindication to NK-1 receptor antagonists and/or 5-HT3 receptor antagonists and other medications that may be used during the trial; 12. Receipt of any treatment with potential antiemetic effects, including pharmacological and non-pharmacological treatments, within 48 hours prior to the start of investigational product administration (refer to the Prohibited Concomitant Treatments table); 13. Participants whose last use of an opioid occurred less than 5 half-lives before the start of investigational product administration; 14. Use of strong CYP3A4 inducers, strong inhibitors, or specific CYP2D6 substrates within 28 days prior to randomization. 15. Participants who have received chemotherapy within 4 weeks prior to surgery; 16. Use of other medications that may affect antiemetic efficacy as determined by the investigator, with the last use occurring less than 5 half-lives before the start of investigational product administration (based on the actual drug label; if the half-life is unknown, a 48-hour washout period should be applied). 17. Participants scheduled to receive anesthetic methods not specified in the protocol, including local anesthesia, regional anesthesia \[e.g., nerve block, neuraxial block (including subarachnoid block, epidural anesthesia, or combined spinal-epidural anesthesia)\], and total intravenous anesthesia; 18. Participants expected to require an in-place nasogastric tube or orogastric tube after surgery completion; 19. Participants expected to be transferred to the ICU for sedation with endotracheal intubation after surgery or those unable to undergo nausea and vomiting record assessments; 20. Participation in another clinical study of a drug or device within 3 months prior to screening (having signed informed consent and received investigational product/device treatment); 21. Daily excessive consumption of tea, coffee, grapefruit/grapefruit juice, pomelo juice, or caffeinated beverages (average \> 8 cups per day, 200 mL per cup) within 14 days prior to randomization; 22. Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in this trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Zhongshan Hospital
RECRUITINGShanghai, Shanghai Municipality, 200032, China
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Tianjin Nankai Hospital
RECRUITINGTianjin, Tianjin Municipality, 300100, China