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临床试验/NCT05001425
NCT05001425Unknown不适用

Association Between the Brain Excitability and Postoperative Delirium in Patients Undergoing Heart Valve Replacement Surgery With Cardiopulmonary Bypass: a Prospective Cohort Study

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
90
试验地点
1
主要终点
The incidence of delirium after cardiac surgery

研究概览

简要总结

The purpose of this study is to explorethe brain excitability in patients undergoing heart valve replacement surgery with cardiopulmonary bypass and the correlation with postoperative delirium

详细描述

Delirium is the most common surgical patients postoperative complications of brain dysfunction. Delirium is a kind of consciousness attention and cognitive function changes of acute brain dysfunction, with volatility and reversibility of postoperative delirium (POD), increased hospital costs and length of hospital stay and mortality rate, and can lower the quality of life, lead to long-term postoperative cognitive dysfunction and dementia. The incidence of postoperative cognitive dysfunction in patients undergoing cardiac valve replacement under cardiopulmonary bypass (CPB) can be as high as 44-53%. However, since the specific mechanism of POD is still not clear, there is still a lack of effective prevention and treatment measures. Therefore, early detection and identification are helpful for the early treatment of POD.When brain injury occurs, the levels of excitatory neurotransmitters (glutamate and aspartate) will rise in a short period of time, and the high concentration of glutamate causes excessive intracellular calcium flow, causing cellular calcium overload, and generating excitatory cytotoxic effects. And abnormal electroencephalogram (EEG) is a kind of due to brain excitability/inhibitory amino acid imbalance caused by brain excitability increased result in abnormal discharge mode, can affect cognitive awareness and activities. Increased brain excitability is harmful to the potential, should avoid to happen. At present, the relationship between brain excitability and POD is still in exploring. Therefore, it is important to clarify the correlation between brain excitability and POD in patients undergoing cardiac valve replacement under CPB for improving the pathogenesis of POD.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • No cognitive impairment was assessed one day before surgery;
  • Patients undergoing elective heart valve replacement under CPB and signed informed consent.

排除标准

  • Non-CPB surgery, macrovascular surgery, heart transplantation, correction of congenital heart disease;
  • Stroke, schizophrenia, depression, Parkinson's disease, epilepsy or dementia;
  • Inability to communicate with language impairment or major hearing or visual impairment;
  • Liver function child-pugh Grade C, severe liver dysfunction;
  • Severe renal insufficiency requires preoperative renal replacement therapy;
  • A past history of intraoperative knowledge.

结局指标

主要结局

The incidence of delirium after cardiac surgery

时间窗: The third day after surgery

Postoperative evaluation delirium occurrence use the The Confusion Assessment Method(CAM) or The Confusion Assessment Method-intensive care unit(CAM-ICU).

Abnormal EEG during surgery

时间窗: Complete EEG information from entry to exit of the operating room

The EEG was collected by Masimo instrument, and the EEG was recognized by the neuroelectrophysiologist, to identify whether the EEG of the patient was epileptic discharge and burst suppression during anesthesia

Plasma excitatory amino acid levels

时间窗: 24 hours after surgery

Venous blood 5ml was collected and centrifuged (3500r/min,10min),sera were separated and put into -80 deep temperature refrigerator for testing plasma excitatory amino acid levels.

次要结局

未报告次要终点

研究者

发起方
General Hospital of Ningxia Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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