Reliability of BIS Monitoring in Neurosurgical Patients
Completed
- Conditions
- Sovra and Intra Tentorial Lesions
- Interventions
- Device: Bispectral Index (BIS Vista, Covidien)
- Registration Number
- NCT01483547
- Lead Sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Neurosurgical Bispectral Index (BIS Vista, Covidien) - Non-neurosurgical Bispectral Index (BIS Vista, Covidien) -
- Primary Outcome Measures
Name Time Method BIS values at LOC, PI and ROC 8 months
- Secondary Outcome Measures
Name Time Method incidence of intraoperative awareness 0, 1, 3, 30 days after surgery intraoperative awareness assessed by BRICE Interview
incidence of postoperative delirium 0, 1, 3, 30 days after surgery assessed by Nursing Delirium Scale and CAM-ICU.
predicted site effect drugs concentration at LOC, PI and ROC 8 months Propofol and Remifentanil site effect concentrations delivered by TCI.
total amount of anesthetic drugs delivered at the end of surgery 8 months recovery time after surgery 8 months Time needed for the patients to completely regain orientation
Trial Locations
- Locations (1)
Istituto Neurologico Carlo Besta
🇮🇹Milan, Italy