Efficacy and Safety of Anrikefon Injection for the Treatment of Postoperative Pain in Patients Undergoing Totally Laparoscopic Radical Distal Gastrectomy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Total Consumption of Sufentanil via PCIA
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Group
Normal Saline via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Placebo Group (Drug)
Anruikfen Intravenous Bolus Injection Group
Anruikefen 1 μg/kg via intravenous bolus injection, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Anruikefen (Intravenous Bolus) (Drug)
Anruikefen Intravenous Infusion Group
Anruikefen 1.5 μg/kg via intravenous infusion, once every 8 hours (q8h), for a total of 6 doses.
干预措施: Anruikefen (Intravenous Infusion) (Drug)
结局指标
主要结局
Total Consumption of Sufentanil via PCIA
时间窗: within 48 Hours after the First Administration Postoperatively
次要结局
未报告次要终点