Postoperative nausea and vomiting (PONV)
Conditions
Interventions
Trial Group:Anruikefen injection, single dose of 1µg/kg, administered once every 8 hours for a total of 7 doses within 48 hours
first dose given within 3 hours postoperatively, diluted to 50ml and infused over 30 minutes
Control Group:Tramadol hydrochloride injection (Shumin), single dose of 50mg, administered once every 8 hours for a total of 7 doses within 48 hours
Sponsors
Beijing Friendship Hospital ,Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18–65 years of age, inclusive; both sexes; 2. ASA Physical Status Classification I, II, and III; 3. Patients who undergo elective general anesthesia and receive symmetric three-port or four-port laparoscopic sleeve gastrectomy; 4. The duration of surgery is less than 4 hours; 5. Agrees to participate in this trial and voluntarily signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1. There is a history of severe cardiovascular, respiratory, neuropsychiatric, and digestive system diseases; 2. It is expected that the patient will require continued endotracheal intubation or nasogastric or orogastric tube placement after surgery. 3. Known allergy to or contraindication for opioid analgesics, as well as other anesthetics and antiemetics that may be administered during the trial. 4. History of drug abuse within 3 months prior to screening, or continuous use of opioid analgesics for more than 10 days for any reason. 5. Patients with severe renal insufficiency; 6. Pregnant and lactating females, as well as subjects who have a plan to become pregnant within the study period or within 3 months after the completion of the study. 7. Subjects who are considered by the investigator to have any other factors that make them ineligible for participation in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of vomiting within 48 hours after the first dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| The duration (hours) from the end of surgery to the first passage of flatus, defecation, oral intake , and ambulation;The proportion of patients receiving rescue analgesia and the total dose of rescue analgesic administered within 24 hours, 48 hours and 72 hours after the first dose administration.;Nausea incidence and severity (NRS score) at 0h–24h, 0h–48h, 0h–72h post first dose;Total duration from end of surgery to discharge (hours);EQ-5D score on post-operative day 30;Proportion of patients receiving antiemetic treatment and total dose of antiemetics within 24, 48 and 72 hours after the first dose;Esting/activity NRS scores at 2h, 4h, 8h, 16h, 24h, 32h, 40h, 48hand 72h after the first dose, and the area under the NRS time curve for 0–24h, 0–48h and 0–72h after the fi;IFEED grading scale scores at 24 hours, 48 hours, and 72 hours after the first dose, as well as the proportion of subjects with scores ranging from 0 to 2, 3 to 5, and >=6 points.;Mortality and readmission rate within 30 days post-operation;Serious Adverse Events (SAEs) during treatment and Treatment-Emergent Adverse Events (TEAEs) related to the study drug;Vomiting incidence at 24 h and 72 h post first dose; | — |
Countries
China
Contacts
Public ContactZhang Zhongtao
Beijing Friendship Hospital ,Capital Medical University
Outcome results
None listed