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

Study Overview
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Brief Summary
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Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.

Official Title
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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.

Conditions
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Intracranial Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Unilateral intracranial tumor<br>Subjects with unilateral intracranial tumor | |
| Control group<br>Subjects without intracranial pathology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres. |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covariates that causes asymmetry between bilaterally derived EEG. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial tumor patients