Influence of Intracranial Lesions on Bispectral Index

Supratentorial Brain Tumor Clinical Trial

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."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060631
• Other study ID #: BIS001
• Status: Completed
• Phase: N/A
• First received: February 1, 2010
• Last updated: June 29, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2009
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Supratentorial Brain Tumor

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	University Medical Center Groningen	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.		one year	No
Secondary	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	No