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Reliability of BIS Monitoring in Neurosurgical Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483547
First Posted: December 1, 2011
Last Update Posted: February 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carla Carozzi, MD, Istittuto Nazionale Neurologico Carlo Besta
  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 Carla Carozzi, MD, Istittuto Nazionale Neurologico Carlo Besta:

Primary Outcome Measures:
  • BIS values at LOC, PI and ROC [ Time Frame: 8 months ]

Secondary Outcome Measures:
  • incidence of intraoperative awareness [ Time Frame: 0, 1, 3, 30 days after surgery ]
    intraoperative awareness assessed by BRICE Interview

  • incidence of postoperative delirium [ Time Frame: 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 [ Time Frame: 8 months ]
    Propofol and Remifentanil site effect concentrations delivered by TCI.

  • total amount of anesthetic drugs delivered at the end of surgery [ Time Frame: 8 months ]
  • recovery time after surgery [ Time Frame: 8 months ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 25, 2011
First Posted: December 1, 2011
Last Update Posted: February 18, 2013
Last Verified: February 2013