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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 不限, China
Total Consumption of Sufentanil via PCIA
Time frame: within 48 Hours after the First Administration Postoperatively
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