NCT00910416

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

September 23, 2016

Status Verified

September 1, 2016

Enrollment Period

1.6 years

First QC Date

May 27, 2009

Last Update Submit

September 22, 2016

Conditions

Anesthesia

Keywords

AnesthesiaMonitoring, IntraoperativeElectroencephalography/*drug effects

Outcome Measures

Primary Outcomes (1)

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

    Statistical analysis of concordance

    at the end of each case

Secondary Outcomes (1)

  • Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence

    at the end of each case

Study Arms (2)

patients receiving iv anesthesia

Drug: propofol, remifentanil, atracuriumDevice: EEG monitoring

patients receiving balanced anesthesia

Drug: propofol, remifentanil, atracurium, sevofluraneDevice: EEG monitoring

Interventions

propofol, remifentanil, atracuriumDRUG

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

patients receiving iv anesthesia
propofol, remifentanil, atracurium, sevofluraneDRUG

dosages are adapted according to clinician's judgment

patients receiving balanced anesthesia
EEG monitoringDEVICE

simultaneous monitoring with Bis and Neurosense

patients receiving balanced anesthesiapatients receiving iv anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgical patients

You may qualify if:

  • Patients requiring either intravenous anesthesia or balanced anesthesia (including sevoflurane)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesia, Hôpital Foch

Suresnes, 92150, France

Location

Related Publications (1)

  • Zikov T, Bibian S, Dumont GA, Huzmezan M, Ries CR. Quantifying cortical activity during general anesthesia using wavelet analysis. IEEE Trans Biomed Eng. 2006 Apr;53(4):617-32. doi: 10.1109/TBME.2006.870255.

    PMID: 16602568BACKGROUND

MeSH Terms

Interventions

PropofolRemifentanilAtracuriumSevoflurane

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPropionatesAcids, AcyclicCarboxylic AcidsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzylisoquinolinesIsoquinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Marc Fischler, MD

    Hôpital Foch

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2009

First Posted

May 29, 2009

Study Start

May 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

September 23, 2016

Record last verified: 2016-09

Locations

FR(1)