The Comparability of Bispectral Index and Neurosense During Anesthesia

September 22, 2016 updated by: Hopital Foch

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Dept of Anesthesia, Hôpital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Surgical patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Device: EEG monitoring
simultaneous monitoring with Bis and Neurosense
Drug: propofol, remifentanil, atracurium, sevoflurane
dosages are adapted according to clinician's judgment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at the end of each case

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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