Anesthesia Clinical Trial
Official title:
The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia
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.
Status | Terminated |
Enrollment | 40 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Dept of Anesthesia, Hôpital Foch | Suresnes |
Lead Sponsor | Collaborator |
---|---|
Hopital Foch |
France,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia | Statistical analysis of concordance | at the end of each case | No |
Secondary | Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence | Statistical analysis of concordance | at the end of each case | No |
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