Influence of Intracranial Lesions on Bispectral Index

Study Overview
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Brief Summary
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The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.

Official Title
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Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness.

Conditions
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Supratentorial Brain Tumor

Intervention / Treatment
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* Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
* Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors. Control group: Neurosurgical patients without intracranial pathology. Exclusion Criteria: Patient refusal Significantly increased intracranial pressure Uncontrolled arterial hypertension Significant coronary artery disease Anticipated difficult airway Decreased level of consciousness Existing motor weakness dominant arm/hand Impaired hearing Nausea, vomiting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with frontal or frontotemporal brain tumor.<br> | Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations<br>* Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study<br>|
| patients without supratentorial brain tumor.<br> | Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations<br>* Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between left- and rightsided BIS values in patients with supratentorial brain tumor during course and Comparison between predicted and measured propofol plasma concentrations during course of the study |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bispectral index, lesions, consciousness