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

Completed

• Conditions: Intracranial Tumor

• Registration Number: NCT00936806
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-10
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-27
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.	2 years

Secondary Outcome Measures

Name	Time	Method
Covariates that causes asymmetry between bilaterally derived EEG.	2 years

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium