Gastrectomy
Conditions
Brief 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.
Interventions
DRUGPlacebo Group
Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
DRUGAnruikefen (Intravenous Bolus)
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
DRUGAnruikefen (Intravenous Infusion)
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Aged between 18 and 70 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. * Surgical incision length \< 8 cm. * Voluntarily agree to participate in the trial and sign the informed consent form.
Exclusion criteria
* 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. * Patients expected to require prolonged endotracheal intubation after surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Consumption of Sufentanil via PCIA | within 48 Hours after the First Administration Postoperatively |
Countries
China
Contacts
Primary ContactBin Ke
Outcome results
None listed