A Phase 2 interventional study of Anrikefon and Dezocine in Gallbladder Stones and Gallbladder Polyps, sponsored by Affiliated Hospital of Guangdong Medical University. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-03.
Sponsored by Affiliated Hospital of Guangdong Medical University · Phase 2, Interventional, and Treatment
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.
88 studies on the registry are indexed under Cholecystolithiasis; 17 are open to participants now.
This study's planned enrollment of 144 is above the median of 100 across 59 interventional studies indexed under Cholecystolithiasis.
Browse Cholecystolithiasis studies →Affiliated Hospital of Guangdong Medical University is the lead sponsor of 12 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group. * Anrikefon Group: 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.
Drug: Anrikefon
* Subjects will undergo screening according to the trial flowchart. Successfully screened subjects will obtain a randomization number prior to administration and will be divided into two groups: the Anrikefon group and the Dezocine group. * Dezocine Group: 5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
Drug: Dezocine
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.
5 mg/dose, IV bolus, q8h. Administered at 0h, 8h, and 16h postoperatively for a total of 3 doses.
Quality of Recovery-15 (QoR-15) scale at 24 hours postoperatively.
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.
Time frame: 24 hours after surgery
Resting and movement pain Numeric Rating Scale (NRS) Area Under the Curve (AUC 0-24h) after the initial dose
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).
Time frame: 24 hours after surgery
Resting and movement (turning over) postoperative pain scores using the Numeric Rating Scale (NRS) at 0h, 2h, 8h, 16h, and 24h postoperatively.
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.
Time frame: 24 hours after surgery
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.
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.
Time frame: 24 hours after surgery
Incidence of shoulder discomfort, back pain, nausea, and vomiting in each group.
During the medical interview, ask the patient whether they have experienced shoulder discomfort, back pain, nausea, or vomiting.
Time frame: 24 hours after surgery
Time to first oral intake, time to first flatus/defecation, and time to first ambulation.
The medical record documents the patient's mealtimes, times of flatulence and bowel movements, and times of getting out of bed to move around.
Time frame: 24 hours after surgery
Sleep quality on postoperative day 1 assessed by the Richards-Campbell Sleep Questionnaire (RCSQ).
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).
Time frame: 24 hours after surgery
Postoperative Brief Pain Inventory (BPI) Scores
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).
Time frame: 24 hours after surgery
Incidence and severity of adverse events (AEs).
Follow-up records document the occurrence and severity of adverse events in patients.
Time frame: 2 weeks post-surgery
12-Lead Electrocardiogram
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).
Time frame: Baseline and the 24 hours After Surgery
Cumulative use of antiemetics within 0-24 hours after the first postoperative dose in each group
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.
Time frame: 24 hours after surgery
Proportion of patients in each group who received antiemetics within 0-24 hours after the first postoperative dose
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.
Time frame: 24 hours after surgery
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anrikefon
Affiliated Hospital of Guangdong Medical University