Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Intravenous Anesthesia (Bis-qCON-IV)

February 12, 2019 updated by: Hopital Foch

Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.

Quantium Medical Company has an ElectroEncephalograph-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)

35

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

  • France
      • 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 above 18 years,
  • 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 by intravenous drugs (propofol and remifentanil),
  • 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 monitors,
  • Patients having a contraindication to Propofol and/or to Remifentanil.

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
Device: qCON Monitor
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 during maintenance of anesthesia
Up to 10 hours
BIS monitoring during maintenance of anesthesia
Time Frame: Up to 10 hours
Measurement of BIS values during maintenance of anesthesia
Up to 10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
qCON monitoring during induction of anesthesia
Time Frame: One day
Measurement of qCON values during induction of anesthesia
One day
BIS monitoring during induction of anesthesia
Time Frame: One day
Measurement of BIS values during induction of anesthesia
One day
qCON monitoring during recovery of anesthesia
Time Frame: One day
Measurement of qCON values during recovery of anesthesia
One day
BIS monitoring during recovery of anesthesia
Time Frame: One day
Measurement of BIS values during recovery of anesthesia
One day
Burst Suppression ratio retrieved by qCON monitoring
Time Frame: One day
Measurement of Burst Suppression ratio values during anesthesia
One day
Burst Suppression ratio retrieved by BIS monitoring
Time Frame: One day
Measurement of Burst Suppression ratio values during anesthesia
One day
qNOX monitoring during anesthesia
Time Frame: One day
Measurement of qNOX values during anesthesia
One day
Periods of loss of signal of qCON
Time Frame: One day
Measurement of qCON values during anesthesia
One day
Periods of loss of signal of BIS
Time Frame: One day
Measurement of BIS values during anesthesia
One day
Intraoperative memorising
Time Frame: One day
Questionnaire for assessment of memorising of surgery by the patient
One day

Collaborators and Investigators

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

Sponsor

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)

December 4, 2018

Primary Completion (Actual)

December 21, 2018

Study Completion (Actual)

December 21, 2018

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

November 22, 2018

First Posted (Actual)

November 26, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/57

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.

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