The Comparability of Bispectral Index and Neurosense During Anesthesia

Hopital Foch

Status: Terminated

Conditions: Anesthesia

Treatments: Device: EEG monitoring; Drug: propofol, remifentanil, atracurium; Drug: propofol, remifentanil, atracurium, sevoflurane

Study type: Observational

Funder types: Other

Identifiers

NCT00910416

2008/22

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

40 participants in 2 patient groups

patients receiving iv anesthesia

Treatment:

Device: EEG monitoring

Drug: propofol, remifentanil, atracurium

patients receiving balanced anesthesia

Treatment:

Device: EEG monitoring

Drug: propofol, remifentanil, atracurium, sevoflurane