The Impact of Perioperative Restrictive Transfusion on Postoperative Cognitive Dysfunction in Elderly Patients Undergoing Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery
研究概览
简要总结
Although blood transfusion is a representative treatment for acute anemia due to blood loss during surgery, it is also a powerful risk factor for postoperative cognitive dysfunction.
'Restrictive transfusion', which transfusions minimal red blood cells, is not only useful for conserving limited blood resources, but also does not worsen prognosis or mortality after surgery. Research has also been reported that severe restrictive transfusion has improved prognosis and mortality.
However, anemia is also one of the risk factors for postoperative complications, including neurocognitive impairment, it is still controversial how much anemia should be allowed in elderly people who are sensitive to ischemia or heart disease.
The purpose of this study is to determine whether the restrictive transfusion policy reduces the frequency of postoperative cognitive dysfunction than the liberal transfusion policy in patients aged 65 years or older who undergo lumbar interbody fusion.
Restrictive transfusion strategy (which initiates transfusion when hemoglobin level is less than 8 g / dL during perioperative period) // liberal transfusion strategy (which initiates transfusion when hemoglobin level is less than 10 g / dL during perioperative period)
详细描述
The Aim of this study was to compare the frequency of postoperative cognitive dysfunction diagnosed 7 days after surgery between two groups.
K-MOCA (Korean-Montreal Cognitive Assessment) is used to evaluate cognitive dysfunction. In addition, plasma inflammatory markers (CRP, IL-6) and GFAP reflecting brain damage were measured before and after surgery to determine whether brain injury caused by systemic inflammatory response is associated with cognitive dysfunction
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 65 years of age or older who receive more than two levels of lumbar interbody fusion
排除标准
- •If patients have anemia (Hb is less than 13 g / dL for men and less than 12 g / dL for women)
- •Those who cannot read the agreement (illiteracy, foreigner, etc.)
- •Have a history of taking medication for mental illness
- •Communication disorders due to neurological diseases (dementia, stroke, seizures, etc.)
- •Less than 23 points on K-MoCA test
- •When fluid loading and volulyte are difficult due to kidney disease
- •Limited blood transfusion due to heart disease
- •Refusal of blood transfusions (religious reasons, etc.)
- •patients who have received a blood transfusion within 6 weeks prior to surgery
- •If continuous observation is impossible after surgery
- •Emergency surgery
结局指标
主要结局
Comparing the frequency of post-operative cognitive dysfunction diagnosed on the 7th day after surgery
时间窗: 7th day after surgery (POD 7)
On the day before the surgery and the seventh day after the surgery, the patient scan K-MOCA (Korean-Montreal Cognitive Assessment). If the difference between the preoperative test results and the post-operative test results is RCI (Reliable Change Index) \<-1.96, it is determined that cognitive dysfunction occurred.
次要结局
未报告次要终点
研究者
Yon Hee Shim
Professor,Department of Anesthesiology and Pain Medicine
Gangnam Severance Hospital