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The Comparability of Bispectral Index and Neurosense During Anesthesia

This study has been terminated.
(Differences between BIS and Neurosense are important. This study can be terminated.)
Sponsor:
Information provided by:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00910416
First received: May 27, 2009
Last updated: January 22, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention
Anesthesia
 Drug: propofol, remifentanil, atracurium
Drug: propofol, remifentanil, atracurium, sevoflurane
Device: EEG monitoring

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Comparability of Bispectral Index and Neurosense During Total Intravenous Anesthesia and Balanced Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hopital Foch:

Primary Outcome Measures:
  • Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia [ Time Frame: at the end of each case ] [ Designated as safety issue: No ]
    Statistical analysis of concordance


Secondary Outcome Measures:
  • Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence [ Time Frame: at the end of each case ] [ Designated as safety issue: No ]
    Statistical analysis of concordance


Estimated Enrollment: 200
Study Start Date: May 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Surgical patients

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00910416

Locations
France
Dept of Anesthesia, Hôpital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Study Chair: Marc Fischler, MD Hôpital Foch
  More Information

Publications:

Responsible Party: Pr Marc Fischler, Hopital Foch
ClinicalTrials.gov Identifier: NCT00910416     History of Changes
Other Study ID Numbers: 2008/22
Study First Received: May 27, 2009
Last Updated: January 22, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hopital Foch:
Anesthesia
Monitoring, Intraoperative
Electroencephalography/*drug effects

Additional relevant MeSH terms:
Anesthetics
Propofol
Sevoflurane
Remifentanil
Atracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Hypnotics and Sedatives
Platelet Aggregation Inhibitors
Hematologic Agents
Anesthetics, Inhalation
Analgesics, Opioid
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on May 16, 2013