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Completed

NCT Number: NCT03753217

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

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™.

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Key information

Conditions

General Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Foch

Suresnes, 92150, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

qCON Monitor

Device

supervision by qCON monitor of the depth of anesthesia

Primary outcomes

  1. qCON monitoring during maintenance of anesthesia

    Time frame: Up to 10 hours

    Measurement of qCON values during maintenance of anesthesia

  2. BIS monitoring during maintenance of anesthesia

    Time frame: Up to 10 hours

    Measurement of BIS values during maintenance of anesthesia

Secondary outcomes

  1. qCON monitoring during induction of anesthesia

    Time frame: One day

    Measurement of qCON values during induction of anesthesia

  2. BIS monitoring during induction of anesthesia

    Time frame: One day

    Measurement of BIS values during induction of anesthesia

  3. qCON monitoring during recovery of anesthesia

    Time frame: One day

    Measurement of qCON values during recovery of anesthesia

  4. BIS monitoring during recovery of anesthesia

    Time frame: One day

    Measurement of BIS values during recovery of anesthesia

  5. Burst Suppression ratio retrieved by qCON monitoring

    Time frame: One day

    Measurement of Burst Suppression ratio values during anesthesia

  6. Burst Suppression ratio retrieved by BIS monitoring

    Time frame: One day

    Measurement of Burst Suppression ratio values during anesthesia

  7. qNOX monitoring during anesthesia

    Time frame: One day

    Measurement of qNOX values during anesthesia

  8. Periods of loss of signal of qCON

    Time frame: One day

    Measurement of qCON values during anesthesia

  9. Periods of loss of signal of BIS

    Time frame: One day

    Measurement of BIS values during anesthesia

  10. Intraoperative memorising

    Time frame: One day

    Questionnaire for assessment of memorising of surgery by the patient

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Official study title

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

Acronym: Bis-qCON-IV

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 26, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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