Trajectory of Recovery in the Elderly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)
研究概览
简要总结
The purpose of this study is to understand how elderly individuals regain their cognitive skills following general anesthesia. The investigators will compare an age stratified group of volunteers who will be evaluated with a series of cognitive tests and a functional MRI. The participants will then be administered general anesthesia for two hours. The investigators will then assess the participants using state of the art tools to determine when participants return to their cognitive baseline.
详细描述
Elderly patients undergoing anesthesia and surgery frequently suffer from postoperative cognitive dysfunction (POCD) and postoperative delirium (PD). The cause of these entities is unknown. It is unclear what part anesthetics play in the development of POCD and PD. The investigators hypothesize that elderly patient's cognitive capacities recover more slowly after receiving general anesthesia, perhaps because they have more limited cognitive reserve. A more prolonged recovery would confound diagnoses of POCD and PD and potentially puts patients who are discharged on the day of surgery at risk of not understanding postoperative instructions. The trajectory of postoperative cognitive recovery has never been explored and elderly participants have been explicitly not included in any type of emergence research. To explore this vital area the investigators propose to study young and elderly volunteers with a combination of two state of the art neuropsychological tests (Postoperative Quality of Recovery Scale and the NIH Toolbox) and functional magnetic resonance imaging. Starting from baseline, the investigators will determine multiple cognitive domains and resting state networks, treat the participants with general anesthesia for two hours while continuing to examine network activity, and then explore the recovery of the cognitive domains and alterations in functional networks using both the PQRS and the NIH Toolbox Cognitive Measures. Participants will be evaluated at 1 month, 6 months, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •40-80 years old
- •American Society of Anesthesiologists (ASA) Physical Status I or II (i.e. Individuals with minimal disease burden)
- •Capable and willing to consent
排除标准
- •Airway assessment as potentially difficult (Mallampati III or greater)
- •Allergies or hypersensitivity to drug or class
- •Chronic Inflammatory conditions such a lupus or system rheumatoid arthritis (arthritis limited to 1 or 2 joints will be acceptable)
- •Patients with diabetes mellitus
- •Patients with a recent illness (within the last 2 weeks)
- •Patients with severe visual or auditory disorder/handicaps
- •English illiteracy
- •Pregnancy
- •Participants not expected to be able to complete the postoperative tests
- •History of malignant hyperthermia
- •Nursing mothers
- •Body Mass Index > 30
- •Patients with significant metal implants in body
- •Current use of cocaine or opiates
- •Current smokers
结局指标
主要结局
Number of Participants Recovered on Postoperative Quality of Recovery Scale (PQRS)
时间窗: 15 min, 60 min, 1 day, 3 days, 7 days, 30 days, 6 months
Cognitive Function using scales of the PQRS to test whether age is associated with the time of return to baseline cognitive function. The PQRS is a brief measurement tool to assess multiple domains of recovery, including cognition, over time. It is scored as recovered / not recovered based on level of performance, within a certain tolerance range, relative to preoperative (baseline) performance - before the general anesthesia / MRI scanning session. Postoperative Quality of Recovery Cognitive Scale at each study timepoint by age decade. Postoperative Quality of Recovery Cognitive
次要结局
- Change in NIH Tool Box Composite(Baseline, 1 day, 7 days, 30 days)
研究者
Joshua Mincer
Assistant Professor
Icahn School of Medicine at Mount Sinai