Postoperative nausea and vomiting (PONV) in adults
Conditions
Interventions
Experimental group:Aprepitant injection 32mg was administered intravenously
Sponsors
The Third Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: To be enrolled in the trial, participants must meet all of the following eligibility criteria: 1) male or female, aged 18-70 years (inclusive); 2) body mass index (BMI) 18-30 kg/m2 (inclusive); 3) patients who planned to undergo elective laparoscopic-assisted gynecological or abdominal surgery under general anesthesia with expected duration of inhalation anesthesia =1 hour and postoperative hospital stay =48 hours; 4) patients with =2 PONV risk factors assessed by investigators (Appendix 2); 5) patients with American Society of Anesthesiologists (ASA) grade I-III (Appendix 3); 6) Female subjects should meet the following conditions: a) At least 1 year after menopause, or b) has been sterilized, or c) be fertile and meet the following conditions: A negative screening blood pregnancy test Participants and their partners are willing to use effective contraception other than hormonal contraceptives or contraceptive patches from the time of informed consent until 30 days after use of the investigational product (see 5.3) and not to donate eggs Nonbreastfeeding and pregnancy 7) If the female partner of a male subject is fertile, the following conditions must be met: a) the subject has undergone a birth control procedure (more than 30 days after vasectomy and no viable sperm), or b) the subject and his/her partner are willing to use effective contraceptive methods other than hormonal contraceptives or contraceptive stickers from the time of signing the informed consent until 30 days after the use of the investigational drug (see 5.3) and do not donate sperm; 8) able to read, understand and complete diary cards; 9) Those who can understand and abide by the trial procedures and methods, voluntarily participate in the trial, and sign the informed consent form in person.
Exclusion criteria
Exclusion criteria: Subjects with any of the following were not eligible for the trial: 1) patients who are scheduled to undergo intrathoracic, transplantation, or central nervous system surgery, or if the occurrence of PONV may have serious consequences; 2) only receiving local anesthesia, such as neuraxial anesthesia (block), peripheral nerve block anesthesia, regional block, local infiltration anesthesia and topical anesthesia; 3) patients expected to be transferred to ICU after surgery; 4) those expected to need nasogastric or orogastric tube insertion within 48 hours after the end of surgery during the screening period; 5) patients with nausea, vomiting or retching for any reason within 24 hours before surgery (except those caused by brushing teeth or bowel preparation); 6) nausea, vomiting or retching caused by any organic diseases (such as intestinal obstruction, etc.) during the screening period; 7) patients with previous history of malignant tumor (except for the indication of this operation); 8) patients with previous or current history of epilepsy, vestibular dysfunction or chronic dizziness; 9) allergic to the active ingredient or excipients of aprepitant injection; 10) receiving aprepitant injection or aprepitant active ingredient within 2 weeks before randomization; 11) received an NK1 antagonist within 2 weeks before randomization (or within 5 half-life periods after last received an NK1 antagonist at randomization, whichever was longer); 12) patients who had received any antiemetic drugs (including but not limited to NK1 antagonist, 5-HT3 receptor antagonist, corticosteroid [except topical medication], Chinese medicine or proprietary Chinese medicine, see Annex 5) or prophylactic antiemetic drugs within 1 week before randomization; 13) use of potent CYP3A4 inhibitors or substrates within 1 week before randomization or in anticipation of the trial (Annex 5); 14) use of potent CYP3A4 inducers within 4 weeks before randomization or in anticipation of the trial period (Annex 5); 15) who used warfarin within 2 weeks before randomization or expected to use warfarin within 2 weeks after randomization; 16) Screening laboratory test results showed any of the following: a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) =2.0 times the upper limit of normal (ULN) and total bilirubin =1.5 times the ULN, b) creatinine = 1.5 times ULN, c) hemoglobin =90g/L; 17) with a history of drug abuse within 6 months before randomization; 18) who participated in a clinical trial and used a trial drug or medical device within 3 months before screening; 19) the presence of any physical or mental illness or condition, as judged by the investigator, that may increase the risk of the trial, affect the adherence of the subjects to the protocol, or affect the completion of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The remission rate of postoperative nausea and vomiting; | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS;PK;PD;The time of first vomiting occurrence;Time of treatment failure;The proportion of subjects without vomiting occurrence; | — |
Countries
China
Contacts
Public ContactWen Ouyang/ Saiying Wang
The Third Xiangya Hospital of Central South University
Outcome results
None listed