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

Study Overview
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Brief Summary
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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™.

Official Title
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Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane

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 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;

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 | up to 10 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia monitoring