The Effect of Ketamine on Immune Function and Prognosis in Patients Undergoing Colorectal Cancer Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- natural killer cell cytotoxicity
研究概览
简要总结
Systemic inflammation caused by surgery may aggravate immunosuppression in immunocompromised cancer patients. The natural killer (NK) cell is a critical part of anti-tumor immunity. ketamine, a N-methyl-D-asparate receptor antangonist, has anti-inflammatory activity and opioid-sparing effect. This study investigate the effect of intraopertaive ketamine administration on immune function in patients undergoing laparoscopic colorectal cancer resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient between 20 and 80 of age with ASA physical status Ⅰ-Ⅲ
- •patient scheduled for laparoscopic colorectal cancer resection
排除标准
- •ASA physical status Ⅳ
- •severe hepatorenal disease
- •heart failure
- •infection
- •increased intracranial pressure, seizure
- •preoperative chemotherapy
- •immune or endocrine disease
- •metastasis to other organ
- •problem with communication
- •pregnancy
- •body mass index > 35 kg/m2
研究组 & 干预措施
ketamine group
Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.
干预措施: Ketamine (Drug)
control group
0.9% saline solution
干预措施: Saline (Drug)
结局指标
主要结局
natural killer cell cytotoxicity
时间窗: postoperative day 2
Natural killer cell cytotoxicity is measured with NK Vue Kit™(ATGen, Gyeonggi-do, Korea).
次要结局
- recurrence(1 year after surgery)
- metastasis(1 year after surgery)
- proinflammatory cytokine(postoperative day 2)