Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anruikefen (Intravenous Bolus), Anruikefen (Intravenous Infusion), Placebo Group.
- Who it may be relevant to
- Registry conditions: Gastrectomy. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Drug Anruikefen (Intravenous Bolus)
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses. - Drug Anruikefen (Intravenous Infusion)
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses. - Drug Placebo Group
Normal Saline administered via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
Primary outcome measures
- Total Consumption of Sufentanil via PCIA [Time frame: within 48 Hours after the First Administration Postoperatively]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tianjin Medical University Cancer Institute & Hospital — Tianjin
Identifiers
NCT: NCT07330063 · E20251321