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."
1 other identifier
observational
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJuly 1, 2011
November 1, 2009
1.1 years
February 1, 2010
June 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
one year
Secondary Outcomes (1)
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
Study Arms (2)
patients with frontal or frontotemporal brain tumor.
patients without supratentorial brain tumor.
Interventions
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
Eligibility Criteria
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
You may qualify if:
- Patients undergoing elective craniotomy for removal of frontal or frontotemporal brain tumors.
- Control group: Neurosurgical patients without intracranial pathology.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medical Center Groningen
Groningen, Provincie Groningen, 9713EZ, Netherlands
Related Publications (1)
Sahinovic MM, Eleveld DJ, Miyabe-Nishiwaki T, Struys MMRF, Absalom AR. Pharmacokinetics and pharmacodynamics of propofol: changes in patients with frontal brain tumours. Br J Anaesth. 2017 Jun 1;118(6):901-909. doi: 10.1093/bja/aex134.
PMID: 28549082DERIVED
Biospecimen
plasma blood
Study Officials
- PRINCIPAL INVESTIGATOR
U Beese, Dr
University Medical Center Groningen
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 2, 2010
Study Start
November 1, 2009
Primary Completion
December 1, 2010
Study Completion
June 1, 2011
Last Updated
July 1, 2011
Record last verified: 2009-11