Postoperative nausea and vomiting (PONV) in adults
Conditions
Interventions
50mg HRS5580 group:HRS5580 50mg was administered intravenously
100mg HRS5580 group:HRS5580 100mg was administered intravenously
200mg HRS5580 group:HRS5580 200mg was administered intravenously
Ondansetron group:Ondansetron 4mg was administered intravenously
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Before starting the test related activities, and voluntarily signing informed consent, fully understand the purpose and significance of the tests, and voluntary compliance with the test process; 2. Plan to undergo elective surgery under general anesthesia and expect the duration of surgery to be =1h; 3. Were 18 one full year of life; 4. 18 kg/m2=BMI=28 kg/m2; 5. The American society of anesthesiologists (ASA) class I ~ II; 6. Expected postoperative hospital stay =72 hours; 7. High risk factors of PONV (female, history of PONV or motion sickness, non-smoking, postoperative use) Opioids)=3; 8. Women of childbearing potential who had a negative blood pregnancy test within 7 days before randomization and were not lactating; Women of childbearing potential were required to use a highly effective contraceptive method for 30 days before the screening period and up to 1 month after the last dose (see Appendix 18.3) and to be without an egg donation or a plan to have children. Male subjects whose partner was a woman of childbearing potential used a highly effective contraceptive from the time they signed the informed consent form until 1 month after the last dose.
Exclusion criteria
Exclusion criteria: 1. Vomiting and/or retching or nausea within 24 hours before surgery (except for vomiting and/or retching or nausea during gastrointestinal preparation); (2) patients with a history of vestibular diseases (including but not limited to peripheral vestibular syndrome, central vestibular syndrome, etc.) or dizziness, and a history of diseases of the digestive tract, central nervous system or other systems that may cause nausea and vomiting; 3. A history of chronic nausea or vomiting/retching. 4. History of new myocardial infarction or unstable angina pectoris, or severe arrhythmia such as atrioventricular block of degree II or above, or NYHA class II or above within 6 months before screening; 5. Any other medical condition that was judged by the investigator to be combined with confounding the evaluation of postoperative nausea and/or vomiting. Laboratory and other tests: 6. Random blood glucose >11.1mmol/L during screening; 7. QTc interval prolongation during screening: male >450ms, female >470ms; 8. Systolic blood pressure =160mmHg or <90mmHg, and/or diastolic blood pressure =100mmHg or <60mmHg before signing ICF and entering the operating room, and clinically significant as judged by the researcher; 9. Abnormal liver function during screening: aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) and/or glutamyltransferase (GGT)=3.0×ULN and/or total bilirubin (TBIL)=1.5×ULN; 10. Abnormal renal function during screening: serum creatinine (Cr)=1.5×ULN and/or dialysis; 11. Hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), syphilis antibody and human immunodeficiency virus (HIV) antibody were positive in the screening period; Concomitant drugs: 12. Known for NK 1 receptor antagonist and/or 5 - HT3 receptor antagonist and test may be used to other drug allergy or taboo; 13. Have received any treatment that may have antiemetic effect within 48 hours before the initiation of the investigational drug, including drug therapy (refer to the list of banned drugs) and non-drug therapy; 14. Subjects whose last opioid use was less than 5 half-lives before starting the investigational drug; Within 28 days before 15. Random use of CYP3A4, strong inducer or particular CYP2D6 substrates (specific see scheme annex 18.4); 16. Subjects who received chemotherapy within 4 weeks before surgery; 17. The researchers determine the use of other drugs affecting anti-nausea effect, the last time from the beginning to use test with shorter than 5 half-life of the drug (the actual instruction shall prevail, the half-life is unknown, according to the 48 h elution). 18. Local anesthetic plan only accept such as nerve block anesthesia or spinal canal block anesthesia or only receive all by intravenous anesthesia; 19. Patients expected to need in situ nasogastric tube or orogastric tube after surgery; 20. Subjects is expected to put into operation the ICU; 21. Participating in clinical trials of other drugs or devices within 3 months before screening (signing informed consent and receiving treatment with investigational drugs/devices); 22. The researchers believe other information/her unsuitable to participate in the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| No vomiting rate within 72 hours after extubation;Incidence of injection-site reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extubation after 24 h, 48 h, 72 h, 96 h, 120 h in complete response rate;Pharmacokinetic;Pharmacodynamics;The time of first vomiting occurrence;Safety;Proportion of subjects who did not experience significant nausea within 24, 48, 72, 96, and 120 hours after extubation;The rate of no vomiting within 24h, 48h, 96h and 120h after extubation;Extubation after 24 h, 48 h, 72 h, 96 h, 120 h ratio did not receive the remedies within subjects;The first time of significant nausea;Time to first receipt of rescue medication; | — |
Countries
China
Contacts
Public ContactWen Ouyang
The Third Xiangya Hospital of Central South University
Outcome results
None listed