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临床试验/NCT04943939
NCT04943939Unknown不适用

Correlation of Electroencephalogram Epileptiform Discharges With Postoperative Delirium During Cardiac Surgery

General Hospital of Ningxia Medical University1 个研究点 分布在 1 个国家目标入组 60 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
60
试验地点
1
主要终点
Incidence of delirium after cardiac surgery

研究概览

简要总结

The purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD

详细描述

Cardiac surgery under cardiopulmonary bypass (CPB) as a result of the surgery itself great trauma and CPB this special process can lead to cerebral hypoperfusion, cerebral ischemia, increased in patients with postoperative neurological complications, the incidence of postoperative cognitive dysfunction can up to 44-53%.Postoperative delirium (POD) is not only increase the incidence of postoperative cognitive dysfunction forward, affect the quality of postoperative recovery and increased hospital costs, also associated with postoperative mortality. Although the clinical use of different drugs and technology improve the POD, but due to the mechanism is still unclear, is still lack of effective control measures. Electroencephalogram (EEG) can measure the cerebral cortex and subcortical local potential activities, to reflect the activities of the neurons in the brain. CPB can cause the abnormal vibration of brain waves, epileptiform discharges is the result of abnormal discharge of brain neurons, which is correlated with the occurrence of cognitive dysfunction.But whether EEG epileptiform discharges is related to the POD is uncertain.While epileptic seizures can be treated with anticonvulsant drugs, so the detection and treatment of early epileptic seizures may have important clinical significance for the occurrence of POD. Therefore, the main purpose of this study is to explore characteristic changes of EEG epileptiform discharges in patients under CPB and correlation with POD, offer the theoretical foundation for delirium early warning and prevention.

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

  • ASA II-III;
  • No cognitive impairment was assessed one day before surgery;
  • Patients undergoing elective CPB cardiac surgery(valvular heart surgery and coronary bypass surgery) 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

Incidence of delirium after cardiac surgery

时间窗: The third day after surgery

Postoperative evaluation delirium occurrence use the CAM or CAM-ICU.

次要结局

  • Epileptic discharge in electroencephalogram during cardiac surgery(Start induction of anesthesia until leave the operating room)

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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