The Effect of Isoflurane Versus Propofol Anesthesia on Alzheimers Disease CSF Markers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Ratio of cerebrospinal fluid tau to amyloid beta
研究概览
简要总结
Previous work in animal models suggests that inhalational anesthetic agents may accelerate Alzheimer's disease pathogenesis, but it is unclear to what extent this may happen in humans. Here, the investigators propose to measure Alzheimer's disease-related neural markers in the cerebrospinal fluid (CSF) of patients exposed to anesthesia while undergoing neurosurgical procedures that require lumbar drain placement. Patients will be randomized to either receive inhalation anesthesia with isoflurane or intravenous anesthesia with propofol.
CSF and blood samples will each be collected at the induction of anesthesia, and then again ten and twenty-four hours later. CSF samples will be assayed for amyloid beta, tau, and other Alzheimer's disease-associated markers; blood samples will be assayed for serum inflammatory markers and used for genotyping studies. These studies should clarify the effect of common anesthetic agents on Alzheimer's disease related neural markers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 and above
- •seen in neurosurgical clinic, and scheduled for operative aneurysm repair or other neurosurgical procedure necessitating lumbar drain placement.
- •ability to speak English.
- •ability to understand consent forms, and to give informed consent.
排除标准
- •age less than 18
- •lumbar drain is not placed
- •not eligible for one of the anesthetics (inhaled isoflurane or IV propofol)
- •inmate of a correctional facility (i.e. prisoners).
- •pregnancy. Pregnancy is ruled out as standard of care before cranial surgery, based on clinical history and/or HCG testing
研究组 & 干预措施
Propofol based intravenous anesthesia
patients will receive propofol based intravenous anesthesia
干预措施: Propofol (Drug)
Isoflurane Based Inhaled Anesthesia
patients will receive isoflurane based inhaled anesthesia
干预措施: Isoflurane (Drug)
结局指标
主要结局
Ratio of cerebrospinal fluid tau to amyloid beta
时间窗: twenty four hours after the induction of anesthesia
次要结局
- the relationship between CSF biomarker changes and serum markers of metabolic and/or inflammatory status(up to 24 hrs after induction of anesthesia)
- the relationship between anesthetic exposure and biomarker changes and serum markers of metabolic and/or inflammatory status(up to 24 hrs after induction of anesthesia)
- the relationship between anesthetic exposure and biomarker changes and neuroimaging results obtained as dictated by routine standard of care(up to 24 hours after induction of anesthesia)
- the relationship between anesthetic exposure and biomarker changes and depth of anesthesia, based on average BIS (bispectral index) monitoring signal(up to 24 hours after induction of anesthesia)
- the relationship between anesthetic exposure and biomarker changes and the time of day that surgery is performed(up to 24 hours after induction of anesthesia)
- the relationship between anesthetic exposure and biomarker changes with genetic polymorphisms in ApoE (apolipoprotein E) and other genes related to inflammation, metabolism, brain function and/or Alzheimer's disease(up to 24 hours after induction of anesthesia)
- the relationship between anesthetic exposure and CSF biomarker changes(up to 24 hrs after induction of anesthesia)
- the relationship between anesthetic exposure and CSF biomarker changes, and demographics (age, gender, and race)(up to 24 hrs after induction of anesthesia)