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

General Anesthesia Clinical Trial

— Bis-qCon-Hal  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03359512
• Other study ID #: 2016/30
• Secondary ID: 2016-A01088-43
• Status: Completed
• Phase: N/A
• Start date: November 21, 2017
• Est. completion date: March 16, 2018

Study information

• Verified date: November 2017
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 16, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• General Anesthesia

Intervention

Device:
• qCON monitor
supervision by qCON monitor of the depth of anesthesia

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	qCON monitoring during maintenance of anesthesia	Measurement of qCON values	up to 10 hours
Secondary	BIS monitoring during maintenance of anesthesia	Measurement of BIS values each 5 seconds during maintenance of anesthesia	One day
Secondary	qCON monitoring during induction of anesthesia	Measurement of qCON values each 5 seconds during induction of anesthesia	One day
Secondary	BIS monitoring during induction of anesthesia	Measurement of BIS values each 5 seconds during induction of anesthesia	One day
Secondary	qCON monitoring during recovery of anesthesia	Measurement of qCON values each 5 seconds during recovery of anesthesia	One day
Secondary	BIS monitoring during recovery of anesthesia during recovery of anesthesia	Measurement of BIS values each 5 seconds	One day
Secondary	Burst Suppression ratio retrieved by qCON monitoring	Measurement of Burst Suppression ratio values each 5 seconds during anesthesia	One day
Secondary	Burst Suppression ratio retrieved by BIS monitoring	Measurement of Burst Suppression ratio values each 5 seconds during anesthesia	One day
Secondary	qNOX monitoring during anesthesia	Measurement of qNOX values each 5 seconds during anesthesia	One day
Secondary	Periods of loss of signal of qCON	Measurement of qCON values each 5 seconds during anesthesia	One day
Secondary	Periods of loss of signal of BIS during anesthesia	Measurement of BIS values each 5 seconds	One day