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临床试验/NCT01772537
NCT01772537终止不适用

The Effect of Anesthesia on Potential Cerebrospinal Fluid (CSF) and Serum Markers of Alzheimer's Disease.

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
14
试验地点
1
主要终点
Changes in Cerebrospinal Fluid (CSF) Levels of Tau

研究概览

简要总结

Alzheimer's disease represents a growing public health problem in developed countries. Although the pathogenesis is not clearly defined, accumulation of extracellular amyloid, neurofibrillary tangles and neuronal loss are the hallmarks of Alzheimer's disease. The effect of anesthetic agents on changes in these proteins in humans is not well characterized, but in-vitro evidence suggests that anesthetic agents can accelerate potential pathogenic mechanisms, such as increasing amyloid formation or rates of apoptosis in cultured cells and increasing amyloid levels in mice. Human data on the effect of anesthetic agents on amyloid and tau proteins is limited to a small series of 11 patients and showed a significant increase in tau levels after exposure to anesthetics. In this study the investigators propose to measure CSF and serum biomarkers in a population of patients with normal CSF dynamics, who are undergoing surgery for repair of a thoracoabdominal aneurysm. The investigators will also obtain preliminary data on whether changes in CSF levels of these proteins are associated with postoperative delirium or cognitive change.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age 21-100 years of age
  • Patients presenting for surgical repair of a thoracoabdominal aneurysm
  • Insertion of a CSF spinal drain for clinically indicated reason

排除标准

  • Patients with pre-existing delirium
  • Inability to speak and understand English
  • Severe hearing impairment, resulting in inability to converse
  • Pregnancy. Pregnancy status will be assessed using a serum pregnancy test during preoperative evaluation as part of the standard of care.

研究组 & 干预措施

Stent graft repair of thoracoabdominal aneurysms isoflurane

Active Comparator

These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive isoflurane as their primary anesthetic.

干预措施: isoflurane (Drug)

Stent graft repair of thoracoabdominal aneurysms propofol

Active Comparator

These patients are patients receiving repair of thoracoabdominal aneurysms using stent grafts. These patients will be randomized to receive propofol as their primary anesthetic.

干预措施: Propofol (Drug)

结局指标

主要结局

Changes in Cerebrospinal Fluid (CSF) Levels of Tau

时间窗: From insertion of spinal drain until removal

Quantitative levels of tau will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane. .

Changes in CSF Levels of Amyloid

时间窗: From insertion of spinal drain until removal

Quantitative levels of amyloid will be measured using ELISA assay technique in pg/ml to compare the differences between the group receiving Propofol and the groups receiving Isoflurane.

次要结局

  • Number of Participants With Delirium as Assessed by the Confusion Assessment Method (CAM)(Immediately after surgery and at 3 and 12 months post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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