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OpenTrials
Completed

NCT Number: NCT03359512

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

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™.

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Key information

Conditions

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 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;

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

Secondary outcomes

  1. BIS monitoring during maintenance of anesthesia

    Time frame: One day

    Measurement of BIS values each 5 seconds during maintenance of anesthesia

  2. qCON monitoring during induction of anesthesia

    Time frame: One day

    Measurement of qCON values each 5 seconds during induction of anesthesia

  3. BIS monitoring during induction of anesthesia

    Time frame: One day

    Measurement of BIS values each 5 seconds during induction of anesthesia

  4. qCON monitoring during recovery of anesthesia

    Time frame: One day

    Measurement of qCON values each 5 seconds during recovery of anesthesia

  5. BIS monitoring during recovery of anesthesia during recovery of anesthesia

    Time frame: One day

    Measurement of BIS values each 5 seconds

  6. Burst Suppression ratio retrieved by qCON monitoring

    Time frame: One day

    Measurement of Burst Suppression ratio values each 5 seconds during anesthesia

  7. Burst Suppression ratio retrieved by BIS monitoring

    Time frame: One day

    Measurement of Burst Suppression ratio values each 5 seconds during anesthesia

  8. qNOX monitoring during anesthesia

    Time frame: One day

    Measurement of qNOX values each 5 seconds during anesthesia

  9. Periods of loss of signal of qCON

    Time frame: One day

    Measurement of qCON values each 5 seconds during anesthesia

  10. Periods of loss of signal of BIS during anesthesia

    Time frame: One day

    Measurement of BIS values each 5 seconds

Sponsors and collaborators

Lead sponsor

Hopital Foch

Other

Registry information

Acronym: Bis-qCon-Hal

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Aug 24, 2018

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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