Anruikefen is a peripherally highly selective kappa receptor agonist that does not easily cross the blood-brain barrier, resulting in a low incidence of central adverse reactions such as respiratory depression, sedation, and addiction. As a Class 1 new drug, it was approved for marketing in China on May 13, 2025, and is indicated for the treatment of postoperative pain following abdominal surgery. Results from two Phase Ⅲ randomized controlled trials (RCTs) of Anruikefen have demonstrated its significant analgesic efficacy, with the incidence of postoperative nausea and vomiting (PONV) being 50% significantly lower than that in the placebo group, which confirms the favorable safety profile of Anruikefen Injection.
Therefore, this investigator-initiated trial (IIT) is designed to further verify the efficacy and safety of Anruikefen in patients undergoing total laparoscopic distal gastrectomy for gastric cancer.
Aged between 18 and 75 years old (inclusive).
American Society of Anesthesiologists (ASA) physical status classification Class I-III.
Body Mass Index (BMI) ranging from 18 kg/m² to 30 kg/m² (inclusive).
Patients scheduled for elective total laparoscopic distal gastrectomy for gastric cancer under general anesthesia, with surgical duration < 5 hours.
Patients undergoing emergency surgery or suffering from trauma.
Patients who undergo conversion to open surgery or laparoscopically assisted distal gastrectomy for gastric cancer during the operation.
Patients who refuse to receive Patient-Controlled Intravenous Analgesia (PCIA).
Patients with a history of prior abdominal surgery.
Parallel
Anruikefen (Intravenous Bolus)
DrugAnruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Anruikefen (Intravenous Infusion)
DrugAnruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Placebo Group
DrugNormal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Total Consumption of Sufentanil via PCIA
Cumulative consumption of sufentanil delivered via patient-controlled intravenous analgesia (PCIA)
Rest numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Dynamic numerical rating scale (NRS) pain score assessed at baseline, 1 hour , 8 hours , 24 hours, and 48 hours after the first study drug administration;
Peak rest numerical rating scale (NRS) pain score
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