Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy

Efficacy and Safety of Anrikefon Injection for Multimodal Postoperative Analgesia in Patients Undergoing Laparoscopic Hepatectomy:A Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial

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.

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.

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.