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Influence of Intracranial Lesions on Bispectral Index

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ClinicalTrials.gov Identifier: NCT01060631
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Supratentorial Brain Tumor Device: BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: "Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
Study Start Date : November 2009
Primary Completion Date : December 2010
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Propofol
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
patients with frontal or frontotemporal 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 without 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


Outcome Measures

Primary Outcome Measures :
  1. Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. [ Time Frame: one year ]

Secondary Outcome Measures :
  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 [ Time Frame: one year ]

Biospecimen Retention:   Samples Without DNA
plasma blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060631


Locations
Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9713EZ
Sponsors and Collaborators
University Medical Center Groningen
Investigators
Principal Investigator: U Beese, Dr University Medical Center Groningen
More Information

Responsible Party: Dr. U. Beese, Department of Anaesthesiology, University Medical Center Groningen,University of Groningen
ClinicalTrials.gov Identifier: NCT01060631     History of Changes
Other Study ID Numbers: BIS001
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: November 2009

Keywords provided by University Medical Center Groningen:
bispectral index
lesions
consciousness

Additional relevant MeSH terms:
Propofol
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics