Low Dose Ketamine Prevent the Postoperative Cognitive Dysfunction in Aged Patients Underwent Orthopaedic Surgery，a Randomized Control Double Blinded Multicenter Clinical Trail
试验速览
- 阶段
- 不适用
- 入组人数
- 484
- 试验地点
- 3
- 主要终点
- Short-term cognitive changes after surgery
研究概览
简要总结
Previous study demonstrated that neuroinflammation induced by surgery is the main cause of the postoperative cognitive dysfunction. As an agonist of NMDA receptor, ketamine is proved to be an anti-inflammation agent. In present study investigators hypothesized that low dose ketamine would prevent the cognition decline after orthopedic surgery in aged patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elder than 60
- •Easily communicated with Chinese
- •Selected to kneel or hip replacement
- •Agree to take part into this clinical trail
排除标准
- •Existing cerebral disease， or have a history of neurological and psychiatric disease including AD, stroke and psychosis
- •Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24
- •Several audition or vision disorder
- •Preoperative systolic Blood pressure over 190mmHg or diastolic pressure >100mmHg
- •Existing a history of hyperthyroidism
- •Patient with glaucoma
- •Unwillingness to comply with the protocol or procedures
研究组 & 干预措施
Ketamine
Ketamine infusion group
干预措施: Ketamine (Drug)
结局指标
主要结局
Short-term cognitive changes after surgery
时间窗: The day before surgery and 7 days after surgery (or before leave hospital)
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the short-term cognitive changes of patients after surgery.
Long-term cognitive changes after surgery
时间窗: The day before surgery and 2 months after surgery
Investigators would use mini-mental state examination(MMSE), Visual reproduction test,digit symbol，digit span,color trail test and Stroop color and word test for measuring the long-term cognitive changes of patients after surgery.
次要结局
未报告次要终点