"Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Supratentorial Brain Tumor
Both
Supratentorial Brain Tumor
Trial Information
"Assessment of the Influence of Intracranial Space Occupying Lesions on the Reliability Off Monitoring of the Bispectral Index for Detection of Return of Consciousness."
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
Type of Study:
Observational
Study Design:
Observational Model: Case Control, Time Perspective: Prospective
Outcome Measure:
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Outcome Time Frame:
one year
Safety Issue:
No
Principal Investigator
U Beese, Dr
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Medical Centre Groningen
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
BIS001
NCT ID:
NCT01060631
Start Date:
November 2009
Completion Date:
June 2011
Related Keywords:
- Supratentorial Brain Tumor
- bispectral index
- lesions
- consciousness
- Brain Neoplasms
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