Automated Anesthesia Guided by the Conox Monitor for Surgery

NCT03540875 | Terminated

• 1 other identifier: 2017/04
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Anesthesia, General

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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)

• Adequate analgesia

  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

• Occurrence of Burst Suppression Ratio (bsr)

  Intraoperative period

• Dose of hypnotic drug

  Intraoperative period

• Dose of analgesic drug

  Intraoperative period

• Medical interventions on the dosage of drugs

  Intraoperative period

Study Arms (2)

Full automation group

EXPERIMENTAL

Full automation control of propofol and remifentanil

Device: Closed loop anesthesia; Drug: Propofol; Drug: Remifentanil

Control group

OTHER

Manual control of of propofol and remifentanil using TCI system

Drug: Propofol; Drug: Remifentanil

Interventions

Closed loop anesthesia 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.

Full automation group

Propofol DRUG

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

Control group; Full automation group

Remifentanil DRUG

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

Control group; Full automation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (3)

Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon

Besançon, Bourgogne-Franche-Comté, 25030, France

Location

Service d'Anesthésie du Centre Clinical

Soyaux, Poitou-Charentes, 16800, France

Location

Service d'Anesthésie, Hôpital Foch

Suresnes, Île-de-France Region, 92151, France

Location

Related Publications (2)

• 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.

  PMID: 21233500 RESULT

• 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.

  PMID: 24995461 RESULT

MeSH Terms

Interventions

Propofol; Remifentanil

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Marc Fischler, MD

  Hôpital Foch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2018
• First Posted: May 30, 2018
• Study Start: July 2, 2018
• Primary Completion: February 18, 2019
• Study Completion: February 18, 2019
• Last Updated: November 5, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)