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临床试验/NCT01870453
NCT01870453撤回不适用

Differential Effects of Various Anesthetic Agents on Cognitive Function in Patients With Alzheimer's Disease

Massachusetts General Hospital1 个研究点 分布在 1 个国家开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Cognitive Function

研究概览

简要总结

The objective of the study is to determine the effects of different anesthetic agents on cognitive function in patients with Alzheimer's disease (AD). The investigators will test the hypothesis that anesthesia with desflurane or propofol, compared to isoflurane or sevoflurane, will have less of an effect on post-operative cognitive dysfunction in patients with AD.

详细描述

Patients with mild-to-moderate Alzheimer's disease who are scheduled to have elective noncardiac, nonneurologic, nonvascular surgery will be recruited at the Massachusetts General Hospital (MGH). The study will first be introduced to patients at their preoperative surgical clinic appointment by his/her surgeon. If patients are interested in participating, they will notify their surgeons, and subsequent recruitment will take place at the MGH Pre-Admission Testing Area (PATA), a clinic for preoperative evaluation and medical optimization. Patient contact and recruitment, however, will only proceed with permission from (1) the patient him/herself and (2) the patient's surgeon. Per the Partners Human Research Committees-approved criteria, if patients do not have capacity for clinical-decision making but express a willingness to participate in the study, a surrogate (i.e. healthcare proxy and/or family member) co-signature will be required on the consent form. On the day of the subject's surgery, the anesthesia team will be allowed to choose one of four anesthetic options (i.e. propofol anesthesia, isoflurane anesthesia, sevoflurane anesthesia, or desflurane anesthesia) based on clinical preference and appropriateness. The research team will be blinded to the anesthetic to which subjects are assigned. Finally, patients will be followed for one year post-operatively with a battery of cognitive tests to determine differences in cognitive trajectory.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with Alzheimer's disease (AD) per Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.
  • Patient recruitment permission granted by his/her surgeon
  • Requires general anesthesia for elective noncardiac, nonneurologic, nonvascular surgery.

排除标准

  • History of neurologic or psychiatric disease (i.e. stroke, psychosis, etc.)
  • Non-native English speaker
  • Severe visual or auditory disorder
  • Sensitivity to sulfites (some propofol formulations at MGH may contain sodium metasulfite).
  • Asthma (sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people).

结局指标

主要结局

Cognitive Function

时间窗: 1 week pre-operatively to 1 year post-operatively

Cognitive function will be assessed using a battery of neuropsychological tests in the domains of attention and executive functions (Trail Making Test, Verbal Fluency Test, Category Switching Test, Symbol Digit Modalities Test), memory (Hopkins Verbal Learning Test-R, Brief Visual Memory Test-R), visuospatial functions (Benton Judgement of Line Orientation Test), and language (Category Fluency Test).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhongcong Xie

Associate Professor of Anaesthesia

Massachusetts General Hospital

研究点 (1)

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