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Comparison of Two Electroencephalograms (EEG) Monitors in Patients Undergoing General Anesthesia With Sevoflurane (Bis-qCon-Hal)

H

Hopital Foch

Status

Completed

Conditions

General Anesthesia

Treatments

Device: qCON monitor

Study type

Interventional

Funder types

Other

Identifiers

NCT03359512
2016-A01088-43 (Other Identifier)
2016/30

Details and patient eligibility

About

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™.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

46 participants in 1 patient group

qCON monitor
Experimental group
Description:
Simultaneous measurement of BIS and qCON
Treatment:
Device: qCON monitor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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