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Clinical Trials/NCT03753217
NCT03753217
Completed
Not Applicable

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

Hopital Foch1 site in 1 country35 target enrollmentDecember 4, 2018
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ConditionsGeneral Anesthesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthesia
Sponsor
Hopital Foch
Enrollment
35
Locations
1
Primary Endpoint
qCON monitoring during maintenance of anesthesia
Status
Completed
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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™.

Registry
clinicaltrials.gov
Start Date
December 4, 2018
End Date
December 21, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

qCON monitoring during maintenance of anesthesia

Time Frame: Up to 10 hours

Measurement of qCON values during maintenance of anesthesia

BIS monitoring during maintenance of anesthesia

Time Frame: Up to 10 hours

Measurement of BIS values during maintenance of anesthesia

Secondary Outcomes

  • Burst Suppression ratio retrieved by BIS monitoring(One day)
  • qCON monitoring during induction of anesthesia(One day)
  • BIS monitoring during recovery of anesthesia(One day)
  • Burst Suppression ratio retrieved by qCON monitoring(One day)
  • Periods of loss of signal of qCON(One day)
  • Periods of loss of signal of BIS(One day)
  • BIS monitoring during induction of anesthesia(One day)
  • qCON monitoring during recovery of anesthesia(One day)
  • qNOX monitoring during anesthesia(One day)
  • Intraoperative memorising(One day)

Study Sites (1)

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