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

Hopital Foch

Status: Completed

Conditions: General Anesthesia

Treatments: Device: qCON Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT03753217

2016/57

Details and patient eligibility

About

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™.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

qCON Monitor

Experimental group

Description:

Simultaneous measurement of BIS and qCON

Treatment:

Device: qCON Monitor