The Comparability of Bispectral Index and Neurosense During Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia

Conditions
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Anesthesia

Intervention / Treatment
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* Drug: propofol, remifentanil, atracurium
* Drug: propofol, remifentanil, atracurium, sevoflurane
* Device: EEG monitoring


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients receiving iv anesthesia<br> | Drug: propofol, remifentanil, atracurium<br>* propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment<br>Device: EEG monitoring<br>* simultaneous monitoring with Bis and Neurosense<br>|
| patients receiving balanced anesthesia<br> | Drug: propofol, remifentanil, atracurium, sevoflurane<br>* dosages are adapted according to clinician's judgment<br>Device: EEG monitoring<br>* simultaneous monitoring with Bis and Neurosense<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia | Statistical analysis of concordance | at the end of each case | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence | Statistical analysis of concordance | at the end of each case | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, Monitoring, Intraoperative, Electroencephalography/*drug effects