Influence of Intracranial Lesions on Bispectral Index

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

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.

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Detailed Description

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Conditions

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Supratentorial Brain Tumor

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with frontal or frontotemporal brain tumor.

BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

Intervention Type DEVICE

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

patients without supratentorial brain tumor.

BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

Intervention Type DEVICE

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

Interventions

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BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

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

Intervention Type DEVICE

BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No