Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
Medtronic - MITG
Conditions:
Intracranial Tumor
Eligibility:
All Genders
18-80 years
Brief Summary
Study of the influence of brain tumor on bilateral electroencephalogram (EEG) during anaesthesia.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00936806
Start Date
January 1 2009
End Date
August 1 2012
Last Update
January 28 2014
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000