General Anesthesia
Conditions
Keywords
anesthesia monitoring
Brief summary
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™.
Interventions
DEVICEqCON monitor
supervision by qCON monitor of the depth of anesthesia
Sponsors
Hopital Foch
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| qCON monitoring during maintenance of anesthesia | up to 10 hours | Measurement of qCON values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| qCON monitoring during induction of anesthesia | One day | Measurement of qCON values each 5 seconds during induction of anesthesia |
| BIS monitoring during induction of anesthesia | One day | Measurement of BIS values each 5 seconds during induction of anesthesia |
| qCON monitoring during recovery of anesthesia | One day | Measurement of qCON values each 5 seconds during recovery of anesthesia |
| BIS monitoring during recovery of anesthesia during recovery of anesthesia | One day | Measurement of BIS values each 5 seconds |
| BIS monitoring during maintenance of anesthesia | One day | Measurement of BIS values each 5 seconds during maintenance of anesthesia |
| Burst Suppression ratio retrieved by BIS monitoring | One day | Measurement of Burst Suppression ratio values each 5 seconds during anesthesia |
| qNOX monitoring during anesthesia | One day | Measurement of qNOX values each 5 seconds during anesthesia |
| Periods of loss of signal of qCON | One day | Measurement of qCON values each 5 seconds during anesthesia |
| Periods of loss of signal of BIS during anesthesia | One day | Measurement of BIS values each 5 seconds |
| Burst Suppression ratio retrieved by qCON monitoring | One day | Measurement of Burst Suppression ratio values each 5 seconds during anesthesia |
Countries
France
Outcome results
None listed