TerminatedNot Applicable

The Comparability of Bispectral Index and Neurosense During Anesthesia

Stopped: Differences between BIS and Neurosense are important. This study can be terminated.

France40 participantsStarted 2009-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia

Timeframe: at the end of each case

Trial details

NCT IDNCT00910416

SponsorHopital Foch

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2010-12

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