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

Not Applicable

Completed

• Conditions: General Anesthesia
• Interventions: Device: qCON Monitor

• Registration Number: NCT03753217
• Lead Sponsor: Hopital Foch

Brief Summary

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™.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-22
• Study First Posted: 2018-11-26
• Study Start: 2018-12-04
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Last Update Submitted: 2019-02-12
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
qCON Monitor	qCON Monitor	Simultaneous measurement of BIS and qCON

Primary Outcome Measures

Name	Time	Method
qCON monitoring during maintenance of anesthesia	Up to 10 hours	Measurement of qCON values during maintenance of anesthesia
BIS monitoring during maintenance of anesthesia	Up to 10 hours	Measurement of BIS values during maintenance of anesthesia

Secondary Outcome Measures

Name	Time	Method
BIS monitoring during recovery of anesthesia	One day	Measurement of BIS values during recovery of anesthesia
Burst Suppression ratio retrieved by qCON monitoring	One day	Measurement of Burst Suppression ratio values during anesthesia
Periods of loss of signal of qCON	One day	Measurement of qCON values during anesthesia
Periods of loss of signal of BIS	One day	Measurement of BIS values during anesthesia
Intraoperative memorising	One day	Questionnaire for assessment of memorising of surgery by the patient
Burst Suppression ratio retrieved by BIS monitoring	One day	Measurement of Burst Suppression ratio values during anesthesia
qCON monitoring during induction of anesthesia	One day	Measurement of qCON values during induction of anesthesia
BIS monitoring during induction of anesthesia	One day	Measurement of BIS values during induction of anesthesia
qCON monitoring during recovery of anesthesia	One day	Measurement of qCON values during recovery of anesthesia
qNOX monitoring during anesthesia	One day	Measurement of qNOX values during anesthesia

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France