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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00936806

Acronym

VISTA

Enrollment

Registered

2009-07-10

Start date

2009-01-31

Completion date

2012-08-31

Last updated

2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracranial Tumor

Keywords

Intracranial tumor patients

Brief summary

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

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Covariates that causes asymmetry between bilaterally derived EEG.	2 years

Countries

Belgium

Outcome results