Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy

Condition(s) studied

Investigational drug(s) / intervention(s)

Anruikefen (Intravenous Bolus): Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Anruikefen (Intravenous Infusion): Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.

Placebo Group: Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Total Consumption of Sufentanil via PCIA — within 48 Hours after the First Administration Postoperatively

Trial sites (1)

More Tianjin Medical University Cancer Institute and Hospital trials in China

Other trials for the same condition