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临床试验/NCT04512989
NCT04512989招募中不适用

Assessing Brain Frailty; The Association Between Pre, Intra and Post-operative Electrophysiological Markers and Postoperative Cognitive Dysfunction

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Correlation of 45 days POCD to intra operative EEG changes

研究概览

简要总结

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery, naming post-operative cognitive dysfunction, is well known.

Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. It was previously found that the presence of cognitive dysfunction 3 months after non-cardiac surgery was associated with increased mortality. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors are related to patient characteristics, type of operation and anesthetic management.

The investigators have recently shown that using different electrophysiological markers, they can monitor attention and perception which might be associated with brain frailty and brain injury.

The aims of this proof of concept study are: (i) to find-out whether attention processes might be in association with brain frailty. (ii) to find our whether brain injury which is expressed by interhemispheric synchronization is is associated with POCD; (iii) to find out whether the level of anesthesia, as measured electrophysiological by perception might be linked primary to POCD.

详细描述

As the population ages and medical progress is made, many elderly patients that previously would not have been candidates for surgery are now undergoing operations. In this group of older patients, brain dysfunction after anesthesia and surgery is well recognized, naming post-operative cognitive dysfunction.

Post-operative cognitive dysfunction (POCD) is a term used to describe subtle changes in cognition, such as memory and executive function. The most commonly seen problems are memory impairment and impaired performance on intellectual tasks. In severe cases, it can lead to inability to perform daily living functions. The reported incidence figures for postoperative cognitive dysfunction vary depending on the group of patients studied, the definition of POCD used, the tests used to establish the diagnosis and their statistical evaluation, the timing of testing, and the choice of control group. The diagnosis of POCD relies on the availability of the neuropsychological tests. In a large prospective multicenter cohort study, it was found that the presence of cognitive dysfunction 3 months after noncardiac surgery was associated with an increased mortality. Furthermore, patients with cognitive decline at 1 week had an increased risk of leaving the labor market prematurely and a higher prevalence of time receiving social transfer payments. The mechanisms leading to cognitive impairment after anesthesia and surgery are not yet fully clear. The risk factors for developing POCD are related to patient characteristics, type of operation and anesthetic management.

Cardiovascular, respiratory, hepatic, and renal insufficiency are all associated with impaired brain performance. It is theoretically obvious that an adequate intraoperative oxygen supply for all vital organs is essential if postoperative cerebral dysfunction is to be avoided. Casai et al found that brain desaturation (rSO2 decrease <75% of baseline) occurred in 40% of elderly patients after noncardiac surgery, and the cerebral desaturation was linked with a high incidence of POCD. A recent systematic review shows that reductions in cerebral oxygen saturation (rSO2) during cardiac surgery may indicate CPB cannula malposition, particularly during aortic surgery. However, only weak evidence links low rSO2 during cardiac surgery to POCD.

POCD is a well-recognized clinical phenomenon of multifactorial origin; emboli, hypoperfusion, inflammation, and patient's preoperative cerebral dysfunction. Meticulous surgical and anesthesiological techniques are important for preventing complications and keeping the risk of POCD to a minimum.

The EEG is an electrophysiological monitoring method used to record electrical activity of the brain, including normal and abnormal activity. In recent years, numerous clinical studies were performed to evaluate whether the use in intraoperative electroencephalography (EEG) to control the depth of anesthesia has any effect on POCD.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 18 years and older undergoing elective cardiac surgery (CABG or valve replacement).

排除标准

  • inability or refusal to provide informed consent,
  • significant visual impairment so that the pictures of the cognitive tests could not be interpreted accurately.
  • profound dementia or aphasia that interfered with the cognitive assessment.
  • inability to speak Hebrew/ Russian or Arabic so that a language barrier was not confused with postoperative cognitive dysfunction.
  • . Any previously documented major neurologic or psychiatric dysfunction

结局指标

主要结局

Correlation of 45 days POCD to intra operative EEG changes

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 45 and is compared to baseline pre surgery cognitive function

Correlation of 45 days POCD, as measured with MOCA test, to intra operative changes in EEG pattern

Assesing btain frailty

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 7 and day 45 and is compared to baseline pre surgery cognitive function

Correlation of success in pre operative cognitive tests, as measured by MOCA test, to post operative cognitive dysfunction (as measured again by MOCA test)

Correlation of Post Operative cognitive dysfunction (POCD) to intra operative EEG changes

时间窗: The diagnosis of cognitive dysfunction is assessed post operative on day 7 and compared to baseline pre surgery cognitive function

Correlation of post operative cognitive dysfunction as measured by cognitive tests (such as MOCA test) to changes in EEG pattern

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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