Skip to main content
Clinical Trials/NCT00910416
NCT00910416
Terminated
Not Applicable

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

Hopital Foch1 site in 1 country40 target enrollmentMay 2009

Overview

Phase
Not Applicable
Intervention
propofol, remifentanil, atracurium, sevoflurane
Conditions
Anesthesia
Sponsor
Hopital Foch
Enrollment
40
Locations
1
Primary Endpoint
Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia
Status
Terminated
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
December 2010
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

patients receiving balanced anesthesia

Intervention: propofol, remifentanil, atracurium, sevoflurane

patients receiving balanced anesthesia

Intervention: EEG monitoring

patients receiving iv anesthesia

Intervention: propofol, remifentanil, atracurium

patients receiving iv anesthesia

Intervention: EEG monitoring

Outcomes

Primary Outcomes

Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia

Time Frame: at the end of each case

Statistical analysis of concordance

Secondary Outcomes

  • Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence(at the end of each case)

Study Sites (1)

Loading locations...

Similar Trials