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

General Anesthesia Clinical Trial

— Bis-qCON-IV  

Official title:

Assessment of the Depth of Anesthesia During Intravenous Anesthesia: Comparison of the Bispectral Index Monitor and the qCON Monitor.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753217
• Other study ID #: 2016/57
• Status: Completed
• Phase: N/A
• Start date: December 4, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: August 2018
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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™.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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 during maintenance of anesthesia	Up to 10 hours
Primary	BIS monitoring during maintenance of anesthesia	Measurement of BIS values during maintenance of anesthesia	Up to 10 hours
Secondary	qCON monitoring during induction of anesthesia	Measurement of qCON values during induction of anesthesia	One day
Secondary	BIS monitoring during induction of anesthesia	Measurement of BIS values during induction of anesthesia	One day
Secondary	qCON monitoring during recovery of anesthesia	Measurement of qCON values during recovery of anesthesia	One day
Secondary	BIS monitoring during recovery of anesthesia	Measurement of BIS values during recovery of anesthesia	One day
Secondary	Burst Suppression ratio retrieved by qCON monitoring	Measurement of Burst Suppression ratio values during anesthesia	One day
Secondary	Burst Suppression ratio retrieved by BIS monitoring	Measurement of Burst Suppression ratio values during anesthesia	One day
Secondary	qNOX monitoring during anesthesia	Measurement of qNOX values during anesthesia	One day
Secondary	Periods of loss of signal of qCON	Measurement of qCON values during anesthesia	One day
Secondary	Periods of loss of signal of BIS	Measurement of BIS values during anesthesia	One day
Secondary	Intraoperative memorising	Questionnaire for assessment of memorising of surgery by the patient	One day