Sovra and Intra Tentorial Lesions
Conditions
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.
Interventions
DEVICEBispectral Index (BIS Vista, Covidien)
BIS values at LOC, PI, ROC.
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BIS values at LOC, PI and ROC | 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed