The Comparability of Bispectral Index and Neurosense During Anesthesia
Information source: Hopital Foch
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anesthesia
Intervention: propofol, remifentanil, atracurium (Drug); propofol, remifentanil, atracurium, sevoflurane (Drug); EEG monitoring (Device)
Phase: N/A
Status: Terminated
Sponsored by: Hopital Foch Official(s) and/or principal investigator(s): Marc Fischler, MD, Study Chair, Affiliation: Hôpital Foch
Summary
The assessment of anesthesia depth was based, until recently, on the evolution of
hemodynamic parameters. Nowadays it can be evaluated by several monitoring methods, derived
from electroencephalogram analysis, namely the Bispectral Index (Aspect Medical Systems,
Newton, USA). A new modality is currently under development: the NeuroSENSE (Cleveland
Medical Devices Inc., Cleveland, OH 44103, USA). The goal of this study is to compare both
monitoring modalities during anesthesia.
Clinical Details
Official title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
Secondary outcome: Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients requiring either intravenous anesthesia or balanced anesthesia (including
sevoflurane)
Exclusion Criteria:
- Pregnant women,
- Allergy to propofol, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- History of neurological disorder or central brain lesion, of muscle disease,
- Patient carrying a pacemaker,
- Patients receiving a psychotropic treatment or a morphine agonist-antagonist,
- Alcoholic patients and patients taking opiates,
- Surgery with extracorporeal circulation,
- Surgical position incompatible with an adequate positioning of the probe.
Locations and Contacts
Dept of Anesthesia, Hôpital Foch, Suresnes 92150, France
Additional Information
Related publications: Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32.
Starting date: May 2009
Last updated: January 22, 2011
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