Reliability of BIS Monitoring in Neurosurgical Patients

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta405 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

405

Conditions

Sovra and Intra Tentorial Lesions

Interventions

Bispectral Index (BIS Vista, Covidien)DEVICE

BIS values at LOC, PI, ROC.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Istituto Neurologico Carlo Besta

Milan, Milan, Italy

Outcomes

Primary Outcomes

BIS values at LOC, PI and ROC

Time frame: 8 months

Secondary Outcomes

incidence of intraoperative awareness

intraoperative awareness assessed by BRICE Interview

Time frame: 0, 1, 3, 30 days after surgery

incidence of postoperative delirium

assessed by Nursing Delirium Scale and CAM-ICU.

Time frame: 0, 1, 3, 30 days after surgery

predicted site effect drugs concentration at LOC, PI and ROC

Propofol and Remifentanil site effect concentrations delivered by TCI.

Time frame: 8 months

total amount of anesthetic drugs delivered at the end of surgery

Time frame: 8 months

recovery time after surgery

Time needed for the patients to completely regain orientation

Time frame: 8 months

Data from ClinicalTrials.gov

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