Markers of Alzheimers Disease and Cognitive Outcomes After Perioperative Care
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
研究概览
简要总结
This study will examine the hypothesis that changes in the cognition (i.e. thinking and memory) after anesthesia and surgery are correlated with changes in markers of Alzheimers Disease in the fluid around the brain and spinal cord (i.e. cerebrospinal fluid, or CSF), and/or changes in brain connectivity. The investigators will also examine whether different types of anesthesia have different effects on these CSF markers of Alzheimers disease, or different effects on thinking and memory after anesthesia and surgery, or differential effects on the correlation between cognitive changes and CSF marker changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, 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
- •Surgical patients 60 years of age or older
- •Surgery scheduled to last at least 2 hours (including time for anesthesia induction, etc)
- •English speaking ability.
- •Ability to give informed consent
排除标准
- •Inmate of a correctional facility (i.e. prisoners).
- •Pregnancy
- •Documented or suspected family or personal history of malignant hyperthermia.
- •Patient unable to receive either propofol or isoflurane due to allergy or other specific contraindication.
研究组 & 干预措施
General anesthesia with Isoflurane
Patients in this arm will undergo general anesthesia with isoflurane as the primary amnestic agent.
干预措施: General anesthesia with isoflurane (Drug)
Total Intravenous Anesthesia with Propofol
Patients in this arm will receive general anesthesia with propofol as the primary amnestic agent.
干预措施: Total intravenous anesthesia with propofol (Drug)
结局指标
主要结局
Correlation Between Perioperative Change in Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
时间窗: Baseline to 6 weeks
Spearman correlation was used here as the CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
Correlation Between Perioperative Change in Ratios of Cerebrospinal Fluid (CSF) Markers of Alzheimers Disease and Perioperative Cognitive Change
时间窗: Baseline to 6 weeks
Spearman correlation was used here as the ratio of CSF markers follow a skewed distribution. Spearman correlation describes the strength of the monotonic relationship between two measures and is bounded between -1 and 1. Negative values indicate an inverse relationship while positive values mean that the variables move in tandem.
次要结局
- Change in CSF Markers of Alzheimers Disease by Anesthetic Agent Group(Baseline to 6 weeks)
- Change in Ratio of CSF Markers of Alzheimers Disease by Anesthetic Agent Group(baseline to 6-weeks)
- Perioperative CSF Tau/Abeta Ratio Change(Baseline to 24 hours)
- Continuous Cognitive Index Score Change Difference Between Anesthetic Agent Groups(Baseline to 6 weeks)