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Reliability of BIS Monitoring in Neurosurgical Patients

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ClinicalTrials.gov Identifier: NCT01483547
Recruitment Status : Completed
First Posted : December 1, 2011
Last Update Posted : February 18, 2013
Information provided by (Responsible Party):

Study Description
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.

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

Study Design

Study Type : Observational
Actual Enrollment : 405 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
Study Start Date : November 2011
Primary Completion Date : December 2012
Study Completion Date : December 2012
Groups and Cohorts

Group/Cohort Intervention/treatment
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.

Outcome Measures

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

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

  2. incidence of postoperative delirium [ Time Frame: 0, 1, 3, 30 days after surgery ]
    assessed by Nursing Delirium Scale and CAM-ICU.

  3. predicted site effect drugs concentration at LOC, PI and ROC [ Time Frame: 8 months ]
    Propofol and Remifentanil site effect concentrations delivered by TCI.

  4. total amount of anesthetic drugs delivered at the end of surgery [ Time Frame: 8 months ]
  5. recovery time after surgery [ Time Frame: 8 months ]
    Time needed for the patients to completely regain orientation

Eligibility Criteria

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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.

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

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 Posted: December 1, 2011    Key Record Dates
Last Update Posted: February 18, 2013
Last Verified: February 2013