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临床试验/NCT02650687
NCT02650687已完成不适用

Optimizing Postoperative Cognition the Elderly

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
178
试验地点
1
主要终点
UDS battery

研究概览

简要总结

This study will recruit surgical patients more than 65 years old. Patients who participate will wear a sticker on their forehead during surgery which monitors their brain waves (electroencephalogram, EEG) and participate in memory testing before and after surgery. Brain wave patterns will be compared between patients who have problems with memory and thinking after surgery and those who do not. The hypothesis is that there will be characteristic brain wave patients for who will go on to have problems with memory and thinking after surgery.

详细描述

Eligible patients will be identified through the computerized scheduling system at the Icahn School of Medicine at Mount Sinai. After informed consent, patients will complete cognitive and tests at least one but not more than 30 days prior to surgery. In the recovery room the Post Anesthesia Recovery Scale (PQRS), and CAM-ICU delirium screening will be administered. Immediate recovery will be recorded using the Postoperative Recovery Scale (PQRS) on postoperative day 1 and 3, and 1 week.

Longterm functional recovery will be measured with the Alzheimer's Disease Research Center (ADRC) Instrumental Activities for Daily Living (IADL-24). Postsurgical complications will be recorded including unplanned ICU admissions, postoperative myocardial infarction and stroke (risk less than 1 % in most cases), wound infection and reoperation. The full cognitive and functional battery will be repeated at 3 months and 1 year after surgery.

研究设计

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

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •65 years of age and older
  • •having major elective non-cardiac surgery requiring general anesthesia requiring at least a 2 day hospital stay

排除标准

  • •previous diagnosis of dementia, stroke, cardiac or intracranial surgery
  • •inability to consent or communicate in English or Spanish
  • •major uncorrected hearing or vision deficit, Parkinson's disease, or major psychiatric disease which will be determined by phone interview and computer medical records abstracted by the primary investigator.

结局指标

主要结局

UDS battery

时间窗: 3 months

Postoperative Cognitive Dysfunction - UDS battery is the standard ADRC neuropsychological battery and will be used to measure cognition

次要结局

  • Processed EEG(1 year)
  • CAM-ICU(1 week)
  • PQRS(1 week)
  • UDS battery(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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