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Completed

NCT Number: NCT01060631

Influence of Intracranial Lesions on Bispectral Index

The purpose of this study is to assess whether BIS values at return of consciousness are different in patients with or without brain tumors.

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Key information

Conditions

Supratentorial Brain Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, Provincie Groningen, 9713EZ, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations

Device

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

Primary outcomes

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

    Time frame: one year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study 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."

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 2, 2010
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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