The Comparability of Bispectral Index and Neurosense During Anesthesia

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00910416
• Other study ID #: 2008/22
• Status: Terminated
• Phase: N/A
• First received: May 27, 2009
• Last updated: September 22, 2016
• Start date: May 2009
• Est. completion date: December 2010

Study information

• Verified date: September 2016
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• propofol, remifentanil, atracurium
propofol, remifentanil, atracurium dosages are adapted according to clinician's judgment
• propofol, remifentanil, atracurium, sevoflurane
dosages are adapted according to clinician's judgment

Device:
• EEG monitoring
simultaneous monitoring with Bis and Neurosense

Locations

Country	Name	City	State
France	Dept of Anesthesia, Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between pairs of Bispectral Index and Neurosense indices during maintenance of anesthesia	Statistical analysis of concordance	at the end of each case	No
Secondary	Concordance between pairs of Bispectral Index and Neurosense indices during induction and emergence	Statistical analysis of concordance	at the end of each case	No