Gallbladder Stones, Gallbladder Polyps
Conditions
Keywords
Laparoscopic Cholecystectomy, Anrikefon, Postoperative Pain Management, Opioid Analgesia
Brief 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.
Interventions
DRUGAnrikefon
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.
DRUGDezocine
5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
Sponsors
Affiliated Hospital of Guangdong Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose | 24 hours after surgery | Pain intensity was assessed using the 11-point Numerical Rating Scale (NRS), ranging from 0 (no pain) to 10 (the most intense pain imaginable). NRS scores were recorded at multiple time points between the first postoperative administration and 24 h ± 1 h, both while the subject was at rest and when turning over, to calculate the AUC 0-24 h. A higher AUC value indicates more severe cumulative pain over 24 hours (a worse outcome). |
| Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively. | 24 hours after surgery | Pain intensity was assessed using an 11-point Numerical Rating Scale (NRS), with scores ranging from 0 (no pain) to 10 (the most intense pain imaginable); higher scores indicate more severe pain (and a poorer prognosis). Participants' NRS scores were recorded at the following time points: within 5 minutes of the first postoperative medication administration, both at rest and while turning over; 2 hours ± 15 minutes after the first postoperative medication administration; 8 hours (within 30 minutes before the second postoperative medication administration); 16 hours (within 30 minutes before the last postoperative medication administration); and 24 hours ± 1 hour. |
| Rescue analgesic utilization: Cumulative consumption of rescue analgesia (meperidine 75 mg) at 0-12h and 0-24h after the first dose, number of rescue interventions, time to first rescue, and the percentage of subjects not requiring rescue analgesia. | 24 hours after surgery | Record the cumulative dose of rescue analgesics (pethidine 75 mg) administered 0-12 hours and 0-24 hours after the patient's first postoperative dose, as well as the time at which rescue analgesics were first administered. |
| Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group. | 24 hours after surgery | During the medical interview, ask the patient whether they have experienced shoulder discomfort, back pain, nausea, or vomiting. |
| Time to first oral intake, time to first flatus/defecation, and time to first ambulation. | 24 hours after surgery | The medical record documents the patient's mealtimes, times of flatulence and bowel movements, and times of getting out of bed to move around. |
| Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ). | 24 hours after surgery | Every morning upon waking, participants immediately used the Richards-Campbell Sleep Questionnaire (RCSQ) to review and evaluate their sleep from the previous night. The total RCSQ score is the average of its five items, with a scoring range from 0 (worst sleep) to 100 (best sleep); a higher score indicates better sleep quality (better outcome). |
| Postoperative Brief Pain Inventory (BPI) Scores | 24 hours after surgery | Twenty-four hours after surgery, the Brief Pain Inventory (BPI) was used to assess participants' pain intensity and the extent to which pain interfered with their daily activities over the past 24 hours. The scale ranges from 0 to 10 points (0 indicates no pain/no interference, and 10 indicates the most intense pain imaginable/complete interference). A higher score indicates more severe pain and a greater impact on daily life (i.e., a worse outcome). |
| Incidence and severity of adverse events (AEs). | 2 weeks post-surgery | Follow-up records document the occurrence and severity of adverse events in patients. |
| 12-Lead Electrocardiogram | Baseline and the 24 hours After Surgery | During the trial, 12-lead ECG examinations were performed at regular intervals to record the ECG diagnosis (normal/abnormal), ECG heart rate (beats per minute), and QT/Qtc/PR (ms). |
| Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group | 24 hours after surgery | Record and compare the total cumulative dose of antiemetic medications prescribed and administered to patients in each group within the first 24 hours after the initial postoperative dose. |
| Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose | 24 hours after surgery | Calculate and compare the percentage of patients in each group who required at least one dose of rescue antiemetic medication within the first 24 hours after the initial postoperative administration. |
Countries
China
Contacts
CONTACTWei Dai, Ph.D., M.D.
Outcome results
None listed