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
  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 Fondazione I.R.C.C.S. Istituto 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Italy
Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Sponsors and Collaborators
Fondazione I.R.C.C.S. Istituto 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 September 22, 2014