NCT00936806已完成不适用
Observational Study of the Differences in Characteristics of the Spontaneous Electroencephalogram, Derived From the Left and Right Hemisphere in Patients With Unilateral Intracranial Tumor During Routine Anesthesia. Comparison With a Control Group Without Intracranial Pathology.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.
研究概览
简要总结
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult ≥ 18 - 80 years old
- •Able to comprehend, sign, and date the written informed consent document to participate in the clinical trial
- •Scheduled for "procedure"
- •ASA Class I, II or III as assigned by the anaesthesiologist
排除标准
- •Allergy or inability to tolerate "product"
- •Body weight less than 70% or more than 130% of ideal body weight
- •Pregnant or nursing females
- •Participation in a clinical trial within the past 30 days
- •Congenital mental disability or congenital anatomical brain abnormality
- •A medical history of cerebrovascular accident or thrombosis
- •A medical history of carotic artery occlusive pathology
- •A medical history of degenerative cerebral pathology (MS, Dementia, ALS, para-or tetraplegia due to a traumatic disruption of the spinal cord)
- •A medical history of severe psychiatric pathology (Schizophrenia, severe depression, alcoholism, drug abuse) Mild depression evoked by coping with the diagnosis of cancer is not excluded
- •Patients with a history of epileptic insults. Patients receiving preventive anti-epileptic treatment due to the tumoral process are not excluded.
- •Patients with low cardiac output conditions due to pre-existing cardiac pathology (Cardiac insufficiency, valve pathology, dysrhythmia, myocardial infarction). Patients presenting with stable coronary artery disease with a normal myocardial function are not excluded)
- •Arterial hypertension is not an exclusion criteria, nor is the use of antihypertensive medication, except beta blockers for their potential interfering effects on spontaneous EEG.
结局指标
主要结局
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.
时间窗: 2 years
次要结局
- Covariates that causes asymmetry between bilaterally derived EEG.(2 years)
研究者
研究点 (1)
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