Reliability of BIS Monitoring in Neurosurgical Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

405 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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The aim of the study is to assess the reliability of Bispectral Index (BIS Vista , Covidien) in neurosurgical patients . BIS values at Loss of Consciousness (LOC), Post Intubation (PI) and Return of Consciousness (ROC) in neurosurgical patients are compared to those of non-neurosurgical patients, during routine anesthesia procedures.

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Detailed Description

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Conditions

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Sovra and Intra Tentorial Lesions

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Neurosurgical

Bispectral Index (BIS Vista, Covidien)

Intervention Type DEVICE

BIS values at LOC, PI, ROC.

Non-neurosurgical

Bispectral Index (BIS Vista, Covidien)

Intervention Type DEVICE

BIS values at LOC, PI, ROC.

Interventions

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Bispectral Index (BIS Vista, Covidien)

BIS values at LOC, PI, ROC.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* BIS \> 90 at baseline (awake)
* ASA I or II

Exclusion Criteria

* GSC \< 15
* anticipated difficult ventilation and/or intubation
* BMI \> 30
* surgical site that does not allow BIS monitoring
* bilateral hearing loss
* not speaking Italian Language

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No