Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane

Hopital Foch1 site in 1 country46 target enrollmentNovember 21, 2017

ConditionsGeneral Anesthesia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: General Anesthesia
Sponsor: Hopital Foch
Enrollment: 46
Locations: 1
Primary Endpoint: qCON monitoring during maintenance of anesthesia
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Quantium Medical Company has an ElectoEcenphalograph-based (EEG-based) algorithm with two outputs: qCON for unconsciousness and qNOX for anti-nociception. qCON, is designed to provide information about the depth of the hypnotic state, similar to that provided by the BIS™.

Registry

clinicaltrials.gov

Start Date

November 21, 2017

End Date

March 16, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hopital Foch

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients affiliated to a national insurance scheme or benefiting from such a program
•Patients having given their written consent.
•Patients that must benefit from a general anesthesia with the aim of a surgical act of a duration of at least one hour
•Patients that must benefit from a general anesthesia including a maintenance by the sevoflurane.
•For the patients taken care in ambulatory surgery, having a telephone and agreeing to communicate their phone number

Exclusion Criteria

•Pregnant or breast-feeding Women
•Patients having a limit of use of the Bispectral Index (BIS) or qCON monitor ,
•Patients having a contraindication in the propofol.
•Patients taken care in ambulatory surgery who could not be contacted within 24 hours following the surgical operation;

Outcomes

Primary Outcomes

qCON monitoring during maintenance of anesthesia

Time Frame: up to 10 hours

Measurement of qCON values

Secondary Outcomes

qCON monitoring during recovery of anesthesia(One day)
BIS monitoring during maintenance of anesthesia(One day)
qCON monitoring during induction of anesthesia(One day)
qNOX monitoring during anesthesia(One day)
Periods of loss of signal of qCON(One day)
BIS monitoring during induction of anesthesia(One day)
Burst Suppression ratio retrieved by qCON monitoring(One day)
Periods of loss of signal of BIS during anesthesia(One day)
BIS monitoring during recovery of anesthesia during recovery of anesthesia(One day)
Burst Suppression ratio retrieved by BIS monitoring(One day)