- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03359512
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
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
-
-
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Suresnes, France, 92150
- Hopital Foch
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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
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supervision by qCON monitor of the depth of anesthesia
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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
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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
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One day
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qCON monitoring during induction of anesthesia
Time Frame: One day
|
Measurement of qCON values each 5 seconds during induction of anesthesia
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One day
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BIS monitoring during induction of anesthesia
Time Frame: One day
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Measurement of BIS values each 5 seconds during induction of anesthesia
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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
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One day
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Burst Suppression ratio retrieved by BIS monitoring
Time Frame: One day
|
Measurement of Burst Suppression ratio values each 5 seconds during anesthesia
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One day
|
qNOX monitoring during anesthesia
Time Frame: One day
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Measurement of qNOX values each 5 seconds during anesthesia
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One day
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Periods of loss of signal of qCON
Time Frame: One day
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Measurement of qCON values each 5 seconds during anesthesia
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One day
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Periods of loss of signal of BIS during anesthesia
Time Frame: One day
|
Measurement of BIS values each 5 seconds
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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
Keywords
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.
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