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

Study Overview
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Brief Summary
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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™.

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

Conditions
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General Anesthesia

Intervention / Treatment
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* Device: qCON Monitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: qCON Monitor<br>Simultaneous measurement of BIS and qCON | Device: qCON Monitor<br>* supervision by qCON monitor of the depth of anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| qCON monitoring during maintenance of anesthesia | Measurement of qCON values during maintenance of anesthesia | Up to 10 hours | 
| BIS monitoring during maintenance of anesthesia | 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 | Measurement of qCON values during induction of anesthesia | One day | 
| BIS monitoring during induction of anesthesia | Measurement of BIS values during induction of anesthesia | One day | 
| qCON monitoring during recovery of anesthesia | Measurement of qCON values during recovery of anesthesia | One day | 
| BIS monitoring during recovery of anesthesia | Measurement of BIS values during recovery of anesthesia | One day | 
| Burst Suppression ratio retrieved by qCON monitoring | Measurement of Burst Suppression ratio values during anesthesia | One day | 
| Burst Suppression ratio retrieved by BIS monitoring | Measurement of Burst Suppression ratio values during anesthesia | One day | 
| qNOX monitoring during anesthesia | Measurement of qNOX values during anesthesia | One day | 
| Periods of loss of signal of qCON | Measurement of qCON values during anesthesia | One day | 
| Periods of loss of signal of BIS | Measurement of BIS values during anesthesia | One day | 
| Intraoperative memorising | Questionnaire for assessment of memorising of surgery by the patient | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia Monitoring