Influence of Intracranial Lesions on Bispectral Index

Completed

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

• Registration Number: NCT01060631
• Lead Sponsor: University Medical Center Groningen

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-11
• Study Start: 2009-11
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Study First Posted: 2010-02-02
• Primary Completion: 2010-12
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-29
• Last Update Posted: 2011-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients without supratentorial brain tumor.	BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations	-
patients with frontal or frontotemporal brain tumor.	BIS values at return of consciousness in patients + predicted and measured propofol plasma concentrations	-

Primary Outcome Measures

Name	Time	Method
Bilateral BIS values at return of consciousness in patients with and without supratentorial brain tumor.	one year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands