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

NCT ID: NCT03753217

Last Updated: 2019-02-15

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

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-04

Study Completion Date

2018-12-21

Brief Summary

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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™.

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 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.
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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Marc Fischler, MD PhD

Role: STUDY_DIRECTOR

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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2016/57

Identifier Type: -

Identifier Source: org_study_id

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