Influence of Intracranial Lesions on Bispectral Index

June 29, 2011 updated by: University Medical Center Groningen

"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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Groningen, Netherlands, 9713EZ
        • University Medical Center Groningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: U Beese, Dr, University Medical Center Groningen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 1, 2010

First Posted (Estimate)

February 2, 2010

Study Record Updates

Last Update Posted (Estimate)

July 1, 2011

Last Update Submitted That Met QC Criteria

June 29, 2011

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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