Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane (Bis-qCon-Hal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03359512
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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™.

Condition or disease Intervention/treatment Phase
General Anesthesia Device: qCON monitor Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane
Actual Study Start Date : November 21, 2017
Actual Primary Completion Date : March 16, 2018
Actual Study Completion Date : March 16, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: qCON monitor
Simultaneous measurement of BIS and qCON
 Device: qCON monitor
supervision by qCON monitor of the depth of anesthesia


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. qCON monitoring during maintenance of anesthesia [ Time Frame: up to 10 hours ]
    Measurement of qCON values


Secondary Outcome Measures :
  1. BIS monitoring during maintenance of anesthesia [ Time Frame: One day ]
    Measurement of BIS values each 5 seconds during maintenance of anesthesia

  2. qCON monitoring during induction of anesthesia [ Time Frame: One day ]
    Measurement of qCON values each 5 seconds during induction of anesthesia

  3. BIS monitoring during induction of anesthesia [ Time Frame: One day ]
    Measurement of BIS values each 5 seconds during induction of anesthesia

  4. qCON monitoring during recovery of anesthesia [ Time Frame: One day ]
    Measurement of qCON values each 5 seconds during recovery of anesthesia

  5. BIS monitoring during recovery of anesthesia during recovery of anesthesia [ Time Frame: One day ]
    Measurement of BIS values each 5 seconds

  6. Burst Suppression ratio retrieved by qCON monitoring [ Time Frame: One day ]
    Measurement of Burst Suppression ratio values each 5 seconds during anesthesia

  7. Burst Suppression ratio retrieved by BIS monitoring [ Time Frame: One day ]
    Measurement of Burst Suppression ratio values each 5 seconds during anesthesia

  8. qNOX monitoring during anesthesia [ Time Frame: One day ]
    Measurement of qNOX values each 5 seconds during anesthesia

  9. Periods of loss of signal of qCON [ Time Frame: One day ]
    Measurement of qCON values each 5 seconds during anesthesia

  10. Periods of loss of signal of BIS during anesthesia [ Time Frame: One day ]
    Measurement of BIS values each 5 seconds


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359512


Locations
Layout table for location information
France
Hopital Foch
Suresnes, France, 92150
Sponsors and Collaborators
Hopital Foch
Investigators
Layout table for investigator information
Principal Investigator: Faiz Sofian, MD Hopital Foch
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT03359512    
Other Study ID Numbers: 2016/30
2016-A01088-43 ( Other Identifier: ANSM )
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hopital Foch:
anesthesia monitoring