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Anesthesia, GeneralConox-loopNCT03540875

Automated Anesthesia Guided by the Conox Monitor for Surgery

A study testing Closed loop anesthesia, Propofol and Remifentanil in people with Anesthesia, General, run by CMC Ambroise Paré at 3 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, General
What is being tested?
Closed loop anesthesia, Propofol and Remifentanil
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
3 sitesFrance
Study dates
2 Jul 2018to 18 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Pregnant or breastfeeding women
  • Patients for which Conox monitor should not be used
  • Allergies to propofol or remifentanil

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon

    Besançon, Bourgogne-Franche-Comté, 25030

  • Service d'Anesthésie du Centre Clinical

    Soyaux, Poitou-Charentes, 16800

  • Service d'Anesthésie, Hôpital Foch

    Suresnes, Île-de-France Region, 92151

Other trials in France

About this study

Official title: Comparison Between Manual Versus Closed-loop Titration of Propofol and Remifentanil Guided by the qCon and qNox Indexes During Induction and Maintenance of General Anesthesia in Adult Patients: a Multicentre Randomized Controlled Study

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.

Read the detailed description

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.

Being tested
Closed loop anesthesia, Propofol, Remifentanil
Keywords
Anesthesia, general, Total intravenous anesthesia, Closed loop anesthesia, Conox, EEG monitoring, qCon, qNox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Closed loop anesthesiaDevice

    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.

  • PropofolDrug

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

  • RemifentanilDrug

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

Study groups in NCT03540875
Study groupRoleWhat they receive
Full automation groupExperimentalFull automation control of propofol and remifentanil
Receives: Device: Closed loop anesthesia; Drug: Propofol; Drug: Remifentanil
Control groupOtherManual control of of propofol and remifentanil using TCI system
Receives: Drug: Propofol; Drug: Remifentanil

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adequate sedation

    Percentage of time with qCon index within the 40-60 range as recommended by the manufacturer of Conox monitor.

    Data from the Conox monitor (signal quality index, qCon index, qNox index, Suppression ratio) are recorded every second.

    Measured: Start of general anesthesia maintenance, i.e. qCon below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion

Secondary outcomes (9)

  1. Adequate analgesia

    Percentage of time with qNox index within the 40-60 range as recommended by the manufacturer of Conox monitor.

    Measured: Start of general anesthesia maintenance, i.e. qNox below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion

  2. Occurrence of Burst Suppression Ratio (bsr)

    Presence of Burst Suppression defined by a rate > 10% for at least one minute

    Measured: Intraoperative period

  3. Dose of hypnotic drug

    Total amount of propofol during the induction and the maintenance of the anesthesia

    Measured: Intraoperative period

  4. Dose of analgesic drug

    Total amount of remifentanil during the induction and the maintenance of the anesthesia

    Measured: Intraoperative period

  5. Medical interventions on the dosage of drugs

    Number of modifications of target of propofol and remifentanil

    Measured: Intraoperative period

  6. Hemodynamic status

    Number of episodes of hemodynamic anomalies having required a treatment

    Measured: Intraoperative period

  7. Fluid therapy

    Intraoperative volume loading and transfusion

    Measured: Intraoperative period

  8. Delay before awakening

    Delay between the cessation of infusion of propofol and remifentanil and extubation

    Measured: 12 hours

  9. Explicit memorization

    Awareness standardized questionnaire

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2018
  2. Study start2 Jul 2018
  3. Primary completion18 Feb 2019
  4. Study completion18 Feb 2019

Why it stopped: Modification of the device

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03540875
Sponsor's protocol ID
2017/04
Acronym
Conox-loop
Status last verified
Oct 2021
First submitted
6 May 2018
Last updated
5 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21233500

  • 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.

    PubMed 24995461

Questions about this trial

What is this clinical trial studying?

A study testing Closed loop anesthesia, Propofol and Remifentanil in people with Anesthesia, General, run by CMC Ambroise Paré at 3 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Modification of the device). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adequate sedation (time frame: Start of general anesthesia maintenance, i.e. qCon below 60 for 30 consecutive seconds for the first time, until the end of propofol et remifentanil infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03540875, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.

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