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临床试验/NCT04481347
NCT04481347招募中不适用

Relationship Between Sleep EEG, Intraoperative EEG and Postoperative Cognitive Dysfunction

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年7月15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
Early postoperative cognitive dysfunction

研究概览

简要总结

The challenge of new recommendations and better adapted practices is pushing to operate patients who are getting older and more fragile. In this context, there is an inevitable increase in the risks associated with care and in particular perioperative neurological complications, of which postoperative cognitive dysfunction (POCD) is the most common.

The interest of perioperative cerebral monitoring and in particular electroencephalography (EEG) to reduce neurological and cognitive damage in surgery has been the subject of abundant research and corresponds to a crucial issue.

From the literature and preliminary results obtained in our clinical research unit, it appears that there is also a relationship between certain characteristics of the peroperative EEG (signal strength and burst suppression) and the occurrence of postoperative cognitive dysfunction (PCOD).

In this context, quantitative analysis of the preoperative sleep EEG and the EEG obtained during general anesthesia could allow the identification of a simple to use biomarker of susceptibility or fragility. To our knowledge, there is no preoperative evaluation strategy using EEG analysis to detect a predisposition to POCD.

The main goal of this observational clinical study is to extend the traditional use of per-operative EEG with pre-operative and post-operative sleep EEG for the detection and prediction of early post-operative cognitive dysfunction.

详细描述

The interest of perioperative brain monitoring to reduce neurological and cognitive damage in surgery has been the subject of much research and corresponds to a crucial issue.

The notion of quantitative EEG covers all the electrical signal processing techniques (fast Fourier transformation, evoked potentials, EEG mapping, etc.) made possible through the digitization of EEG data and the development of software to process these signals. In this context, EEG-derived indices have been set up to monitor hypnosis during general anesthesia. Between 0 (deep hypnosis) and 100 (awakening), the Bispectral Index (BIS) integrates in its calculation the percentage of fast waves, the degree of wave synchronization and the periods of EEG suppression (or "Burst suppression") and allows an adaptation of the dosage of anesthetic products according to its value.

Avoiding too deep anesthesia through neuro-monitoring could help to reduce postoperative delirium by reducing the burst suppression pattern.

Pre-operative cognitive status assessment :

The investigators observe a great delay in the means implemented to have an objective evaluation of cognitive disorders in preoperative care.

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

  • Major patients (≥ 18 years )
  • Eligible for an interventional radiology procedure or surgery under general anesthesia
  • Patients informed and having expressed their non-opposition to participation in this research

排除标准

  • Patients under 18 years old
  • Severe pre-existing cognitive impairment (preoperative mini-mental state examination (MMSE) < 24)
  • Patient opposed to protocol participation
  • Pregnant woman
  • Patient under judicial protection
  • Patient without affiliation to a social security scheme
  • Emergency procedure

结局指标

主要结局

Early postoperative cognitive dysfunction

时间窗: Change between day -1 and day 5

Score obtained following evaluation of the patient's cognitive function using the Montreal Cognitive Assessment questionnaire MoCA (0-30; higher score indicates better performance)

次要结局

  • Burst suppression duration(Duration of the surgical intervention or interventional neuroradiology procedure (maximum 1 day))
  • Spindle amplitude on sleep EEG(Change between day -1 and day 5)
  • Spindle frequency on sleep EEG(Change between day -1 and day 5)
  • Variations in alpha power on sleep EEG(Change between day -1 and day 5)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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