postoperative nausea and vomiting
Conditions
Interventions
Experimental Grou:Aprepitant capsules 80mg P.O. (4 hours preoperatively) + dexamethasone injection 10mg I.V. (at the start of surgery) + ondansetron injection 8mg I.V. (30 minutes prior to the end of
Control Group:Dexamethasone injection 10mg I.V. (at the start of surgery) + ondansetron injection 8mg I.V. (30 minutes prior to the end of surgery)
Sponsors
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Age is between 18 years old and 65 years old. 2.Patients who are scheduled for primary laparoscopic bariatric metabolic surgery. 3.BMI is greater than or equal to 32.5 kg/cm^2. 4.BMI is greater than or equal to 27.5 and less than 32.5, and meets at least two components of metabolic syndrome, or has comorbidities. 5.Patients agree to participate in the study and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with severe emotional or psychiatric disorders who, in the investigator's opinion, are not suitable for inclusion in the study. 2. Patients who have undergone other non-bariatric surgeries. 3. Patients who have undergone revision/secondary bariatric surgery. 4. Patients who have participated in other clinical trials within the past 4 weeks. 5. Patients with any of the following abnormal laboratory results: 1. ALT or AST > 2.5 times the upper limit of normal; 2. Bilirubin > 1 times the upper limit of normal; 3. Creatinine > 1 times the upper limit of normal. 6. Patients who are taking or have taken any of the following CYP3A4 inducers within 30 days prior to the first day of treatment, and who, in the investigator's opinion, may affect the efficacy of the study drug. 7. Patients who are taking or have taken any of the following CYP3A4 substrates and inhibitors within 7 days prior to the first day of treatment, and who, in the investigator's opinion, may significantly increase the risk of adverse events related to the study drug. 8. Patients who are taking or have taken pimozide, terfenadine, astemizole, or cisapride within 7 days prior to the first day of treatment. 9. Patients who have used the following antiemetics within 48 hours prior to the first day of treatment: 5-HT3 receptor antagonists (such as ondansetron), phenothiazines (such as prochlorperazine), butyrophenones (such as haloperidol), benzamides (such as metoclopramide), domperidone, cannabinoids, herbs with potential antiemetic effects, scopolamine, or cinnarizine. 10. Patients who have received any dose of systemic corticosteroids within 72 hours prior to the first day of treatment, excluding topical and inhaled corticosteroids. 11. Patients who have experienced vomiting and/or dry retching, nausea, etc. within 24 hours prior to 1 day before surgery. 12. Patients with a history of allergy to aprepitant, ondansetron, or dexamethasone. 13. Patients with a history of allergy to fosaprepitant, olanzapine, ondansetron, or dexamethasone. 14. Patients with other contraindications to bariatric surgery. 15. Patients with a prolonged QT interval on electrocardiogram. 16. Patients with cardiac arrhythmias such as atrial fibrillation. 17. Patients with a history of heart disease such as heart failure. 18. Patients who, in the investigator's opinion, are not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate of PONV at 72 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate of PONV at 24 hours postoperatively;Complete control rate of PONV at 24 hours and 72 hours postoperatively; | — |
Countries
China
Contacts
Public ContactXiaodong Shan
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Outcome results
None listed