Postoperative nausea and vomiting
Conditions
Interventions
Test group:Fosaprepitant combined with palonosetron and dexamethasone
Control group:Placebo combined with palonosetron and dexamethasone
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Female
Age
20 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients who are going to undergo gynecological tumor surgery; 2.ASA grade I-II; 3.Age: 20-70.
Exclusion criteria
Exclusion criteria: 1.The patient did not agree to participate in the clinical study; 2.ASA grade III-IV; 3.The patient had any of the following conditions within 12 months before operation: myocardial infarction, severe / unstable angina pectoris, coronary artery bypass grafting, congestive heart failure, cerebrovascular accident, pulmonary embolism; Or the following conditions are occurring: arrhythmia >= grade 2 according to nci-ctcae standard, history of QT interval prolongation or taking any drug known to cause QT prolongation; 4.Allergic to fosaprepitant, aprepitant, dexamethasone, palonosetron or other 5-HT3 antagonists; 5.Mental incapacity or major emotional or mental disorder; 6.Abnormal liver function (alanine aminotransferase or aspartate aminotransferase>= 2 times the upper limit of normal value) or abnormal renal function (serum creatinine >= 2.5 times the upper limit of normal value); 7.History of nausea and vomiting within 24 hours before operation; 8.The following antiemetic drugs are being taken or have been taken within 48 hours before the operation: 5-hydroxytryptamine 3 (5-HT3) antagonist, benzalkamine (such as haloperidol), cyclopromazine, domperidone, Chinese herbal medicine with potential antiemetic effect, olanzapine, phenothiazine (such as chlorpromazine), scopolamine, etc. (this is not an exhaustive list of drugs); 9.Participated in the previous study of aprepitant or fosaprepitant, or took the study drug in the past 4 weeks; 10.Other conditions that the researcher thinks cannot be included in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate(CRR) within 24 hours after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response rate(CRR)24-48h,48-72h after surgery;Complete control rate(CCR)0-24h,24- 48h,48-72h after surgery;Severity of nausea and vomiting;Time to first nausea or vomiting;Rescue antiemetic use;VAS pain score;15-item quality of recovery scoring system (QoR-15);Occurrence of adverse effects; | — |
Countries
China
Contacts
Public ContactXie Jingdun
Sun Yat-sen University Cancer Center
Outcome results
None listed