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Influence of Intracranial Lesions on Bispectral Index

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01060631
Enrollment
40
Registered
2010-02-02
Start date
2009-11-30
Completion date
2011-06-30
Last updated
2011-07-01

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

Conditions

Supratentorial Brain Tumor

Keywords

bispectral index, lesions, consciousness

Brief summary

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

Interventions

DEVICEBIS 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

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.one year

Secondary

MeasureTime 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 studyone year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026