Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Phase
Phase 4
Started
2026-08-30
Last updated
2026-09-03
Condition(s) studied
Postoperative Acute Pain
Investigational drug(s) / intervention(s)
Anruikefon 1 μg/kg per dose GroupAnruikefon 100 μg per dose GroupControl group →
Anruikefon 1 μg/kg per dose Group: Anruikefon 1 μg/kg/dose, once every 8 hours (q8h), for a total of 6 doses.
Anruikefon 100 μg per dose Group: Anruikefon 100 μg per dose, once every 8 hours (q8h), for a total of 6 doses.
Control group: 0.9% Sodium Chloride Injection, via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Study summary
A single-center, randomized, double-blind, placebo-controlled trial design will be adopted to investigate whether Anruikefon can significantly reduce the consumption of sufentanil via PCIA pumps within 48 hours postoperatively compared with placebo.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Aged ≥ 18 years;
* American Society of Anesthesiologists (ASA) physical status classification I-III;
* Body mass index (BMI): 18 kg/m² ≤ BMI ≤ 30 kg/m²;
* Patients scheduled to undergo laparoscopic hepatectomy under general anesthesia with estimated operation duration ≤ 5 hours;
* Agree to participate in this trial and voluntarily sign the informed consent form.
Exclusion Criteria:
* Patients with a history of severe cardiopulmonary disease, neuropsychiatric disorders, digestive system diseases, chronic dizziness or vestibular dysfunction;
* Patients undergoing emergency surgery or trauma patients;
* Intraoperative conversion to open laparotomy;
* History of abdominal surgery within the past 3 months;
* Patients undergoing liver transplantation or with metastasis to other organs;
* Patients requiring synchronous resection of organs other than the gallbladder, extrahepatic bile ducts and intestines due to intraoperative clinical needs;
* Severe renal dysfunction (estimated glomerular filtration rate \<30 mL/min/1.73 m²);
* Laboratory findings or clinical evaluation indicating hypothyroidism or hypokalemia graded ≥ Grade 3 per CTCAE v6.0;
* Subjects who experienced nausea, retching or vomiting within 24 hours before anesthesia induction (excluding those caused by bowel preparation);
* Patients expected to require postoperative mechanical ventilation via endotracheal intubation or naso/orogastric tube placement for more than 24 hours;
* Known allergy or contraindication to opioids and other anesthetics, antiemetics that may be administered during the trial.
* Use of drugs with analgesic, antiemetic or anti-inflammatory effects with unknown half-life within 14 days prior to randomization; or the interval between the last administration and randomization is shorter than 5 half-lives or the duration of drug effect (whichever is longer). Such drugs include, but are not limited to, opioid analgesics, non-opioid analgesics, antiemetics (or drugs with antiemetic properties), sedative-hypnotics, sedative anesthetics, glucocorticoids and other drugs with analgesic or antiemetic effects.
* Subjects with any other factors deemed by the investigator(s) to render them unsuitable for participation in this clinical study.
Primary outcome measure(s)
Consumption of sufentanil via PCIA within 48 hours after the first study drug administration — 0-48 hours post first study drug dose
Trial sites (1)
Facility
City
Region
Status
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou
Guangdong
More Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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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