The Comparability of Bispectral Index and Neurosense During Anesthesia

Terminated

• Conditions: Anesthesia
• Interventions: Drug: propofol, remifentanil, atracurium; Drug: propofol, remifentanil, atracurium, sevoflurane; Device: EEG monitoring

• Registration Number: NCT00910416
• Lead Sponsor: Hopital Foch

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-27
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-05-29
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients receiving iv anesthesia	propofol, remifentanil, atracurium	-
patients receiving iv anesthesia	EEG monitoring	-
patients receiving balanced anesthesia	propofol, remifentanil, atracurium, sevoflurane	-
patients receiving balanced anesthesia	EEG monitoring	-

Primary Outcome Measures

Name	Time	Method
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia	at the end of each case	Statistical analysis of concordance

Secondary Outcome Measures

Name	Time	Method
Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence	at the end of each case	Statistical analysis of concordance

Trial Locations

Locations (1)

Dept of Anesthesia, Hôpital Foch; 🇫🇷 Suresnes, France