Kognitive Störungen Nach Elektiver Wirbelsäulenchirurgie Bei Älteren
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- postoperative delirium - incidence
研究概览
简要总结
Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades.
It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age ≥ 60 years
- •scheduled for elective spine surgery without opening the dura
- •patient can give informed consent him-/herself
- •German native speaker
排除标准
- •dementia or neurodegenerative disease
- •psychiatric disease
- •prescription of CNS-active medication (e.g. antidepressants, antipsychotics, sedatives, alpha-1-antagonists)
- •impossible to participate in follow-up
- •participation in an interventional trial
- •electronic or displacable metallic implants
- •active neoplasm
结局指标
主要结局
postoperative delirium - incidence
时间窗: ≤ 3 days postoperatively
screening through Nu-DESC (Nursing Delirium Screening Scale) ≥ 2 and verification of screening procedure by DSM-V (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) criteria once during each shift
次要结局
- pre- and postoperative intelligence(baseline and 3 months postoperatively)
- postoperative delirium - duration(≤ 3 days postoperatively or until delirium resolves)
- Patient Reported Quality of life(baseline and 3 months postoperatively)
- postoperative delirium - severity(≤ 3 days postoperatively or until delirium resolves)
- postoperative cognitive dysfunction - severity(baseline and 3 months postoperatively)
- Markers of systemic inflammation(≤ 2 days postoperatively)
- Patient Reported Quality of life - 2(baseline and 3 months postoperatively)
- Markers of oxidative and metabolic stress(≤ 2 days postoperatively)
- Structural magnetic resonance imaging(baseline and 3 months postoperatively)
- Cerebral vasculature(baseline)
- Markers of neuroinflammation(≤ 2 days postoperatively)
- Anxiety and depression(baseline and 3 months postoperatively)
- Frailty(baseline and 3 months postoperatively)
- Functional magnetic resonance imaging(baseline and 3 months postoperatively)
- Genetic polymorphisms(baseline)