About this trial
This study is a multicenter, randomized, 1:1 parallel-group controlled clinical trial designed to evaluate the efficacy and safety of Anrikefon for postoperative analgesia in patients undergoing elective laparoscopic cholecystectomy (LC) under general anesthesia. Enrolled patients were randomly assigned to two groups (the Anrikefon group and the dizocine group) and received regular intravenous administration of the respective medication following the corresponding surgical procedure. The primary efficacy endpoint was the Quality of Recovery (QoR-15 score) at 24 hours postoperatively, combined with the Numerical Rating Scale (NRS), the Brief Pain Inventory (BPI), sleep quality (RCSQ), and postoperative recovery progress (time to first meal, first flatus, and first ambulation, etc.) for a comprehensive evaluation of efficacy; At the same time, safety indicators-including adverse events (such as nausea and vomiting, and shoulder and back pain), vital signs, and laboratory test results-were systematically monitored during the follow-up period to comprehensively evaluate the clinical utility of this protocol.
Eligibility criteria
Qualifiers
1.18 ≤ Age ≤ 70 years, no gender restriction.
2.American Society of Anesthesiologists (ASA) physical status classification I-II.
3.18 kg/m² ≤ BMI ≤ 30 kg/m².
4.Subjects undergoing elective LC under general anesthesia, with an estimated -surgical duration of ≤2 hours (including 1h).
Disqualifiers
1.History of allergy to nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, or intraoperative anesthetics specified in the protocol.
2.Severe systemic diseases that, in the investigator's judgment, may significantly increase surgical risk or interfere with pain assessment (e.g., uncontrolled hypertension [SBP ≥170 mmHg and/or DBP ≥105 mmHg], uncontrolled hyperglycemia [fasting blood glucose ≥11.1 mmol/L], recent severe respiratory tract infection, severe gastritis, gastric/duodenal ulcers, upper abdominal surgery within 3 months, severe hepatic impairment [Child-Pugh score >9], chronic kidney disease [eGFR <60 mL/min/1.73m²]).
3.Substance abuse: Current drug or alcohol dependency.
4.Special populations: Pregnant or lactating women; any other conditions deemed unsuitable by the investigator.
Trial design
Treatments tested in this trial
- Anrikefon
- Dezocine