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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 (Responsible Party):
Hopital Foch
ClinicalTrials.gov Identifier:
NCT00910416
First received: May 27, 2009
Last updated: September 22, 2016
Last verified: September 2016
  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:


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


Enrollment: 40
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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Hopital Foch
ClinicalTrials.gov Identifier: NCT00910416     History of Changes
Other Study ID Numbers: 2008/22 
Study First Received: May 27, 2009
Last Updated: September 22, 2016
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
Remifentanil
Sevoflurane
Atracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Platelet Aggregation Inhibitors
Anesthetics, Inhalation
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 28, 2016