postoperative nausea and vomiting
Conditions
Interventions
Anrikefon group:A working solution of Anrikefon at a concentration of 10 µg/ml was prepared in a total volume of 100ml. The loading dose was 60 µg (volume 6 ml). The PCA pump was set with a maintenanc
Sufentanil group:A working solution of sufentanil at a concentration of 0.5 µg/ml was prepared in a total volume of 100 ml. The loading dose was 2 µg (volume 4 ml). The PCA pump was set with a mainten
Sponsors
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18–65 years; 2. ASA classification I–III; 3. Scheduled gynecological laparoscopic surgery (e.g., ovarian cyst enucleation) under general anesthesia, with an estimated surgical duration of 1–4 hours; 4. Apfel simplified risk score >= 2 points (moderate-to-high risk of PONV); 5. Written informed consent obtained from patients.
Exclusion criteria
Exclusion criteria: 1. Patients were excluded if they had any of the following: allergy to Anrikefon or other trial-related drugs; 2. Long-term use of antiemetics, emetics, opioids, or glucocorticoids; 3. Pregnancy or lactation; 4. Developmental delay, mental illness, or severe neurological disorders; 5. Presence of serious underlying diseases such as moderate-to-severe hepatic or renal insufficiency (Child-Pugh class B or above), intestinal obstruction/gastroparesis, severe cardiopulmonary diseases (e.g., acute exacerbation of chronic obstructive pulmonary disease, heart failure); 6. Other diseases that may present with nausea and vomiting (e.g., reflux esophagitis, hepatitis, gastric ulcer); 7. Refusal to cooperate with the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of postoperative nausea and vomiting at 24 hours postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Numeric rating scale (NRS) pain scores at rest and during activity at 24h and 48h postoperatively;Proportion of subjects receiving rescue analgesic or antiemetic drugs postoperatively;Time to first flatus;Subject satisfaction scores regarding PONV prophylaxis at 24 h and 48 h after surgery;Time to first vomiting (emesis or retching) or first rescue treatment within 48 hours postoperatively, whichever occurs earlier.;Postoperative Quality of Recovery-15 (QoR-15) scores of subjects at 24 h and 48 h postoperatively;Incidence of adverse reactions within 48 hours postoperatively, including respiratory depression, pruritus, dizziness, shivering and somnolence;Nausea and vomiting scores at 2 h,24 h, and 48 h postoperatively;Cumulative consumption of patient-controlled analgesia (PCA) solution within 48 hours postoperatively; | — |
Countries
China
Contacts
Public ContactXu Zhendong
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Outcome results
None listed