Effect of Anrikefon on PONV in patients undergoing gynecological laparoscopic surgery with PCIA

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: 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 maintenance rate of 1 ml/h, a bolus dose of 3 ml per demand, and a lockout time of 15 minutes.;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 maintenance rate of 1 ml/h, a bolus dose of 2 ml per demand, and a lockout time of 15 minutes.; CONDITION: postoperative nausea and vomiting PRIMARY OUTCOME: incidence of postoperative nausea and vomiting at 24 hours postoperatively; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 6e42ff886ef05f75735cf96cd2255a29d1982f8c
First added on: Sep 12, 2026