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

NCT ID: NCT03359512

Last Updated: 2018-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-21

Study Completion Date

2018-03-16

Brief Summary

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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™.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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qCON monitor

Simultaneous measurement of BIS and qCON

Group Type EXPERIMENTAL

qCON monitor

Intervention Type DEVICE

supervision by qCON monitor of the depth of anesthesia

Interventions

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qCON monitor

supervision by qCON monitor of the depth of anesthesia

Intervention Type DEVICE

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Faiz Sofian, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Foch

Locations

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Hopital Foch

Suresnes, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01088-43

Identifier Type: OTHER

Identifier Source: secondary_id

2016/30

Identifier Type: -

Identifier Source: org_study_id

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