Influence of Intracranial Lesions on Bispectral Index

This study has been completed.
Sponsor:
Information provided by:
University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01060631
First received: February 1, 2010
Last updated: June 29, 2011
Last verified: November 2009

February 1, 2010
June 29, 2011
November 2009
December 2010   (final data collection date for primary outcome measure)
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. [ Time Frame: one year ] [ Designated as safety issue: No ]
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01060631 on ClinicalTrials.gov Archive Site
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 [ Time Frame: one year ] [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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."

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

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma blood

Probability Sample

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

Supratentorial Brain Tumor
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
  • patients with frontal or frontotemporal brain tumor.
    Intervention: Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
  • patients without supratentorial brain tumor.
    Intervention: Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2011
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01060631
BIS001
No
Dr. U. Beese, Department of Anaesthesiology, University Medical Center Groningen,University of Groningen
University Medical Centre Groningen
Not Provided
Principal Investigator: U Beese, Dr University Medical Centre Groningen
University Medical Centre Groningen
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP