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

Intracranial Tumor Clinical Trial

— VISTA  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00936806
• Other study ID #: 2008/666
• Status: Completed
• Phase: N/A
• First received: July 9, 2009
• Last updated: January 27, 2014
• Start date: January 2009
• Est. completion date: August 2012

Study information

• Verified date: January 2014
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Tumor

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Medtronic - MITG

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asymmetry of EEG extracted indices obtained from either healthy or diseased hemispheres.		2 years	No
Secondary	Covariates that causes asymmetry between bilaterally derived EEG.		2 years	No

External Links

•   website of the University Hospital Ghent