Affiliated Hospital of Guangdong Medical University
Phase
Phase 2
Started
2026-09-01
Last updated
2026-08-03
Condition(s) studied
Gallbladder StonesGallbladder Polyps
Investigational drug(s) / intervention(s)
AnrikefonDezocine
Anrikefon: 1.0 µg/kg per dose, administered by intravenous bolus injection every 8 hours at 0, 8, and 16 hours postoperatively, for a total of 3 doses. Specific preparation: Dilute 1.0 µg/kg of Anrikefon with 0.9% sodium chloride injection to a total volume of 10 mL.
Dezocine: 5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
* 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).
* 5.Voluntarily agree to participate in the study and sign the informed consent form (ICF).
Exclusion Criteria:
* 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.
* 5.Acute severe cholecystitis attack within the past 7 days, or subjects in whom malignant gallbladder lesions cannot be ruled out.
* 6.Presence of sleep disorders requiring pharmacological intervention; concomitant psychiatric disorders.
Primary outcome measure(s)
Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively. — 24 hours after surgery The QoR-15 scale was used 24 hours after surgery to assess the quality of patients' postoperative recovery. The total score of the QoR-15 scale ranges from 0 to 150, with higher scores indicating a better quality of postoperative recovery.
Trial sites (2)
Facility
City
Region
Status
Affiliated Hospital of Guangdong Medical University
Zhanjiang
Guangdong
The Second Affiliated Hospital of Guangdong Medical University
Zhanjiang
Guangdong
More Affiliated Hospital of Guangdong Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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