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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
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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."

Resource links provided by NLM:

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

Further study details as provided by University Medical Centre Groningen:

Primary Outcome Measures:
  • Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

plasma blood


Enrollment: 40
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060631

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

No publications provided

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
Study First Received: February 1, 2010
Last Updated: June 29, 2011
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Propofol
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on May 23, 2013