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Reliability of BIS Monitoring in Neurosurgical Patients

F

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status

Completed

Conditions

Sovra and Intra Tentorial Lesions

Treatments

Device: Bispectral Index (BIS Vista, Covidien)

Study type

Observational

Funder types

Other

Identifiers

NCT01483547
BISnch2011

Details and patient eligibility

About

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.

Enrollment

405 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

405 participants in 2 patient groups

Neurosurgical
Treatment:
Device: Bispectral Index (BIS Vista, Covidien)
Non-neurosurgical
Treatment:
Device: Bispectral Index (BIS Vista, Covidien)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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