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 (VISTA)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Intracranial Tumor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00936806

2008/666

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

80 participants in 2 patient groups

Unilateral intracranial tumor

Description:

Subjects with unilateral intracranial tumor

Control group

Description:

Subjects without intracranial pathology