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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03753217
Acronym
Bis-qCON-IV
Enrollment
35
Registered
2018-11-26
Start date
2018-12-04
Completion date
2018-12-21
Last updated
2019-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthesia

Keywords

Anesthesia Monitoring

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™.

Interventions

supervision by qCON monitor of the depth of anesthesia

Sponsors

Hopital Foch
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
qCON monitoring during maintenance of anesthesiaUp to 10 hoursMeasurement of qCON values during maintenance of anesthesia
BIS monitoring during maintenance of anesthesiaUp to 10 hoursMeasurement of BIS values during maintenance of anesthesia

Secondary

MeasureTime frameDescription
qCON monitoring during recovery of anesthesiaOne dayMeasurement of qCON values during recovery of anesthesia
BIS monitoring during recovery of anesthesiaOne dayMeasurement of BIS values during recovery of anesthesia
Burst Suppression ratio retrieved by qCON monitoringOne dayMeasurement of Burst Suppression ratio values during anesthesia
Burst Suppression ratio retrieved by BIS monitoringOne dayMeasurement of Burst Suppression ratio values during anesthesia
qCON monitoring during induction of anesthesiaOne dayMeasurement of qCON values during induction of anesthesia
Periods of loss of signal of qCONOne dayMeasurement of qCON values during anesthesia
Periods of loss of signal of BISOne dayMeasurement of BIS values during anesthesia
Intraoperative memorisingOne dayQuestionnaire for assessment of memorising of surgery by the patient
qNOX monitoring during anesthesiaOne dayMeasurement of qNOX values during anesthesia
BIS monitoring during induction of anesthesiaOne dayMeasurement of BIS values during induction of anesthesia

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026