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Automated Anesthesia Guided by the Conox Monitor for Surgery

NCT ID: NCT03540875

Last Updated: 2021-11-05

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

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-02

Study Completion Date

2019-02-18

Brief Summary

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This study compares automated administration of propofol and remifentanil versus manual administration during general anesthesia for a surgery. The closed-loop coadministration of propofol and remifentanil is guided by qCon and qNox indexes from the Conox monitor.

Detailed Description

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Several monitors are currently proposed to evaluate the depth of hypnosis. The Conox monitor differentiates itself from the other brain monitor by calculating two EEG indexes, the qCon and the qNox. The qCon corresponds to the depth of the sedation and the qNox relates to the probability that a nociceptive stimulation triggers a movement of the patient. A controller allowing the automated titration of propofol guided by the qCon and remifentanil guided by the qNox has been developed. In preparation for a large multi-center control trial, this prospective randomized study evaluates the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one arm in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion (TCI) systems, and the second arm in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain qCon between 40 and 60, the recommended range during anesthesia by the manufacturer. It is expected the combined closed-loop anesthesia system group to do similar or better control to maintain the qCon in the desired range.

Conditions

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Anesthesia, General

Keywords

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Anesthesia, general Total intravenous anesthesia Closed loop anesthesia Conox EEG monitoring qCon qNox

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Full automation group

Full automation control of propofol and remifentanil

Group Type EXPERIMENTAL

Closed loop anesthesia

Intervention Type DEVICE

Propofol and Remifentanil are administered automatically using a closed-loop system.

The goal of this study is to compare manual titration versus automated titration of propofol and remifentanil in adult patients undergoing surgery guided by the electro-cortical activity. The aim in both group is to maintain the qCon in the range 40-60 during induction and maintenance of general anesthesia using the propofol in TCI mode. But also the qNox in the range 40-60 using remifentanil. The controller is based on a Proportional-Integral-derivative algorithm which steers a target to the pumps during induction and maintenance of general anesthesia.

Propofol

Intervention Type DRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Remifentanil

Intervention Type DRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Control group

Manual control of of propofol and remifentanil using TCI system

Group Type OTHER

Propofol

Intervention Type DRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Remifentanil

Intervention Type DRUG

The dosage is modified automatically by the device or according to the new medical prescription.

Interventions

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Closed loop anesthesia

Propofol and Remifentanil are administered automatically using a closed-loop system.

The goal of this study is to compare manual titration versus automated titration of propofol and remifentanil in adult patients undergoing surgery guided by the electro-cortical activity. The aim in both group is to maintain the qCon in the range 40-60 during induction and maintenance of general anesthesia using the propofol in TCI mode. But also the qNox in the range 40-60 using remifentanil. The controller is based on a Proportional-Integral-derivative algorithm which steers a target to the pumps during induction and maintenance of general anesthesia.

Intervention Type DEVICE

Propofol

The dosage is modified automatically by the device or according to the new medical prescription.

Intervention Type DRUG

Remifentanil

The dosage is modified automatically by the device or according to the new medical prescription.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Scheduled surgery for at least one hour
* Consent for participation
* Affiliation to the social security system

Exclusion Criteria

* Pregnant or breastfeeding women
* Patients for which Conox monitor should not be used
* Allergies to propofol or remifentanil
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CMC Ambroise Paré

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fischler, MD

Role: STUDY_CHAIR

Hôpital Foch

Locations

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Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon

Besançon, Bourgogne-Franche-Comté, France

Site Status

Service d'Anesthésie du Centre Clinical

Soyaux, Poitou-Charentes, France

Site Status

Service d'Anesthésie, Hôpital Foch

Suresnes, Île-de-France Region, France

Site Status

Countries

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France

References

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Liu N, Chazot T, Hamada S, Landais A, Boichut N, Dussaussoy C, Trillat B, Beydon L, Samain E, Sessler DI, Fischler M. Closed-loop coadministration of propofol and remifentanil guided by bispectral index: a randomized multicenter study. Anesth Analg. 2011 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.

Reference Type RESULT
PMID: 21233500 (View on PubMed)

Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti M, Ramos Y, Serra R, Jospin M, Pineda P, Gambus P. Monitoring hypnotic effect and nociception with two EEG-derived indices, qCON and qNOX, during general anaesthesia. Acta Anaesthesiol Scand. 2014 Sep;58(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4.

Reference Type RESULT
PMID: 24995461 (View on PubMed)

Other Identifiers

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2017/04

Identifier Type: -

Identifier Source: org_study_id