The Comparability of Bispectral Index and Neurosense During Anesthesia

Sponsor

Hopital Foch (Other)

Overall Status

Terminated

CT.gov ID

NCT00910416

Collaborator

(none)

Enrollment

Location

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia	Drug: propofol, remifentanil, atracurium Drug: propofol, remifentanil, atracurium, sevoflurane Device: EEG monitoring

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

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

Arm

Intervention/Treatment

patients receiving iv anesthesia

Drug: propofol, remifentanil, atracurium

propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment

Device: EEG monitoring

simultaneous monitoring with Bis and Neurosense

patients receiving balanced anesthesia

Drug: propofol, remifentanil, atracurium, sevoflurane

dosages are adapted according to clinician's judgment

Device: EEG monitoring

simultaneous monitoring with Bis and Neurosense

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.