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Reliability of BIS Monitoring in Neurosurgical Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carla Carozzi, MD, Istittuto Nazionale Neurologico Carlo Besta
ClinicalTrials.gov Identifier:
NCT01483547
First received: November 25, 2011
Last updated: February 15, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Sovra and Intra Tentorial Lesions
 Device: Bispectral Index (BIS Vista, Covidien)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients

Further study details as provided by Istittuto Nazionale Neurologico Carlo Besta:

Primary Outcome Measures:
  • BIS values at LOC, PI and ROC [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of intraoperative awareness [ Time Frame: 0, 1, 3, 30 days after surgery ] [ Designated as safety issue: No ]
    intraoperative awareness assessed by BRICE Interview

  • incidence of postoperative delirium [ Time Frame: 0, 1, 3, 30 days after surgery ] [ Designated as safety issue: No ]
    assessed by Nursing Delirium Scale and CAM-ICU.

  • predicted site effect drugs concentration at LOC, PI and ROC [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Propofol and Remifentanil site effect concentrations delivered by TCI.

  • total amount of anesthetic drugs delivered at the end of surgery [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • recovery time after surgery [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Time needed for the patients to completely regain orientation


Enrollment: 405
Study Start Date: November 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Neurosurgical Device: Bispectral Index (BIS Vista, Covidien)
BIS values at LOC, PI, ROC.
Non-neurosurgical Device: Bispectral Index (BIS Vista, Covidien)
BIS values at LOC, PI, ROC.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients undergoing elective craniotomy and elective spinal cord and column surgery.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483547

Locations
Italy
Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Sponsors and Collaborators
Istittuto Nazionale Neurologico Carlo Besta
  More Information

No publications provided

Responsible Party: Carla Carozzi, MD, Doctor, Dept. of Neuroanesthesia and Intensive Care, Istittuto Nazionale Neurologico Carlo Besta
ClinicalTrials.gov Identifier: NCT01483547     History of Changes
Other Study ID Numbers: BISnch2011
Study First Received: November 25, 2011
Last Updated: February 15, 2013
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013