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临床试验/NCT03805685
NCT03805685已完成不适用

The Influence of Preoperative Risk Factors on Perioperative Neurocognitive Disorders in Patients Scheduled for Non-cardiac Surgery

Université Libre de Bruxelles1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
1
主要终点
Pre-operative MMSE

研究概览

简要总结

Perioperative neurocognitive disorders (PND's) remain an important complication after surgery. After many years of speculating about the etiology of this complication, currently studies are pointing to an inflammatory cascade being set in motion.

This prospective study is designed to examine preoperative lifestyle factors (such as sedentary behavior) associated with postoperative cognitive impairment in a group of patients undergoing non-cardiac surgery.

The objectives in our study are to:

identify perioperative risk factors for the development of PND's measure the incidence and duration of perioperative neurocognitive disorders in a known high-risk group of elective surgical patients measure a peripheral inflammatory marker (interleukin 6: IL-6) in the same group of surgical patients

详细描述

Perioperative neurocognitive disorders remain an important complication after surgery. After many years of speculating about the etiology of this complication, currently studies are pointing to an inflammatory cascade being set in motion. Following the combination of surgery/ anesthesia, high molecular group box protein 1 (HMGB1) is released. This damage-associated molecular pattern (DAMP) binds to pattern recognition receptors (PRR) on circulating bone marrow-derived monocytes (BM-DMs). Through an intracellular signaling pathway, the transcription factor NF-kappaB passes into the nucleus, is activated and increases expression and release of pro-inflammatory cytokines. These in turn disrupt the blood brain barrier. Within the brain parenchyma the chemokine MCP-1 (also referred to as CCL2) is upregulated and attracts the BM-DMs through binding to its receptor, CCR2. In turn, this activates the resident quiescent microglia. Together, the BM-DMs and activated microglia release HMGB1 and pro-inflammatory cytokines that disrupt long-term potentiation (LTP) thereby blocking synaptic plasticity changes that are required for the cognitive functions of learning and memory.

Unfortunately, treatment currently is lacking, however optimising lifestyle seems to be a promising pathway in a murine population.

This prospective study is designed to examine preoperative lifestyle factors (such as sedentary behavior) associated with postoperative cognitive impairment in a group of patients undergoing non-cardiac surgery.

Prior to surgery, patients will have a baseline MMSE (mini mental state examination) assessment. At the same time, a standardized history form will be completed to document pertinent patient information, with special emphasis on patterns of smoking and ethanol consumption. French IPAQ data will be collected as well as the Geriatric Depression Scale.

Right before the surgery, a peripheral blood sample will be drawn (to analyse IL-6 levels).

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
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Signed written consent
  • Patients scheduled for non-cardiac surgery (with a duration of 1 to 4 hours)

排除标准

  • Lack of comprehension of the French, English or Dutch language
  • Visual or auditory impairment
  • Any other reason that makes patients unable to perform cognitive testing

结局指标

主要结局

Pre-operative MMSE

时间窗: 12 hours

Mini mental state examination will be evaluated prior to the surgery

MMSE 6 weeks post-operative

时间窗: 6 weeks

Mini mental state examination will be evaluated 6 weeks after surgery

MMSE 3 months post-operative

时间窗: 3 months

Mini mental state examination will be evaluated 3 months after surgery

次要结局

  • Concentration of patient's baseline pre-operative peripheral IL-6(12 hours)
  • Concentration of patient's post-operative peripheral IL-6 ; 24 hours post-operative(24 hours)
  • Concentration of patient's post-operative peripheral IL-6; 6 hours post-operative(24 hours)

研究者

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

Sarah Saxena

Anesthesiologist; Principal Investigator

Université Libre de Bruxelles

研究点 (1)

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