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

August 23, 2018 updated by: Hopital Foch
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™.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

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

      • Suresnes, France, 92150
        • Hopital 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

Description

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;

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: qCON monitor
Simultaneous measurement of BIS and qCON
supervision by qCON monitor of the depth of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qCON monitoring during maintenance of anesthesia
Time Frame: up to 10 hours
Measurement of qCON values
up to 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BIS monitoring during maintenance of anesthesia
Time Frame: One day
Measurement of BIS values each 5 seconds during maintenance of anesthesia
One day
qCON monitoring during induction of anesthesia
Time Frame: One day
Measurement of qCON values each 5 seconds during induction of anesthesia
One day
BIS monitoring during induction of anesthesia
Time Frame: One day
Measurement of BIS values each 5 seconds during induction of anesthesia
One day
qCON monitoring during recovery of anesthesia
Time Frame: One day
Measurement of qCON values each 5 seconds during recovery of anesthesia
One day
BIS monitoring during recovery of anesthesia during recovery of anesthesia
Time Frame: One day
Measurement of BIS values each 5 seconds
One day
Burst Suppression ratio retrieved by qCON monitoring
Time Frame: One day
Measurement of Burst Suppression ratio values each 5 seconds during anesthesia
One day
Burst Suppression ratio retrieved by BIS monitoring
Time Frame: One day
Measurement of Burst Suppression ratio values each 5 seconds during anesthesia
One day
qNOX monitoring during anesthesia
Time Frame: One day
Measurement of qNOX values each 5 seconds during anesthesia
One day
Periods of loss of signal of qCON
Time Frame: One day
Measurement of qCON values each 5 seconds during anesthesia
One day
Periods of loss of signal of BIS during anesthesia
Time Frame: One day
Measurement of BIS values each 5 seconds
One day

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Faiz Sofian, MD, Hopital Foch

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 (Actual)

November 21, 2017

Primary Completion (Actual)

March 16, 2018

Study Completion (Actual)

March 16, 2018

Study Registration Dates

First Submitted

November 6, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 2, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2016/30
  • 2016-A01088-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on General Anesthesia

Clinical Trials on qCON monitor

Subscribe