- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483547
Reliability of BIS Monitoring in Neurosurgical Patients
February 15, 2013 updated by: Carla Carozzi, MD, Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Reliability of Bispectral Index for Depth of Anesthesia Monitoring in Neurosurgical Patients
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
405
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Milan, Italy, 20133
- Istituto Neurologico Carlo Besta
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients undergoing elective craniotomy and elective spinal cord and column surgery.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Neurosurgical
|
BIS values at LOC, PI, ROC.
|
Non-neurosurgical
|
BIS values at LOC, PI, ROC.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BIS values at LOC, PI and ROC
Time Frame: 8 months
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
incidence of intraoperative awareness
Time Frame: 0, 1, 3, 30 days after surgery
|
intraoperative awareness assessed by BRICE Interview
|
0, 1, 3, 30 days after surgery
|
incidence of postoperative delirium
Time Frame: 0, 1, 3, 30 days after surgery
|
assessed by Nursing Delirium Scale and CAM-ICU.
|
0, 1, 3, 30 days after surgery
|
predicted site effect drugs concentration at LOC, PI and ROC
Time Frame: 8 months
|
Propofol and Remifentanil site effect concentrations delivered by TCI.
|
8 months
|
total amount of anesthetic drugs delivered at the end of surgery
Time Frame: 8 months
|
8 months
|
|
recovery time after surgery
Time Frame: 8 months
|
Time needed for the patients to completely regain orientation
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
December 1, 2012
Study Registration Dates
First Submitted
November 25, 2011
First Submitted That Met QC Criteria
November 29, 2011
First Posted (Estimate)
December 1, 2011
Study Record Updates
Last Update Posted (Estimate)
February 18, 2013
Last Update Submitted That Met QC Criteria
February 15, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- BISnch2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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