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

Not Applicable

Completed

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

• Registration Number: NCT03359512
• Lead Sponsor: Hopital Foch

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™.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-11
• Study First Submitted: 2017-11-06
• Study Start: 2017-11-21
• Study First Submitted QC: 2017-11-30
• Study First Posted: 2017-12-02
• Primary Completion: 2018-03-16
• Study Completion: 2018-03-16
• Last Update Submitted: 2018-08-23
• Last Update Posted: 2018-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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;

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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

Secondary Outcome Measures

Name	Time	Method
qCON monitoring during induction of anesthesia	One day	Measurement of qCON 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 maintenance of anesthesia	One day	Measurement of BIS values each 5 seconds during maintenance of 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
BIS monitoring during induction of anesthesia	One day	Measurement of BIS values each 5 seconds during induction of anesthesia
Burst Suppression ratio retrieved by qCON monitoring	One day	Measurement of Burst Suppression ratio values each 5 seconds during anesthesia
Periods of loss of signal of BIS during anesthesia	One day	Measurement of BIS values each 5 seconds
BIS monitoring during recovery of anesthesia during recovery of anesthesia	One day	Measurement of BIS values each 5 seconds
Burst Suppression ratio retrieved by BIS monitoring	One day	Measurement of Burst Suppression ratio values each 5 seconds during anesthesia

Trial Locations

Locations (1)

Hopital Foch; 🇫🇷 Suresnes, France