The Comparability of Bispectral Index and Neurosense During Anesthesia

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00910416

Enrollment

Registered

2009-05-29

Start date

2009-05-31

Completion date

2010-12-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Keywords

Anesthesia, Monitoring, Intraoperative, Electroencephalography/*drug effects

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.

Interventions

DRUGpropofol, remifentanil, atracurium

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

DRUGpropofol, remifentanil, atracurium, sevoflurane

dosages are adapted according to clinician's judgment

DEVICEEEG monitoring

simultaneous monitoring with Bis and Neurosense

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026