Automated Anesthesia Guided by the Conox Monitor for Surgery

Anesthesia, General Clinical Trial

— Conox-loop  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03540875
• Other study ID #: 2017/04
• Status: Terminated
• Phase: N/A
• Start date: July 2, 2018
• Est. completion date: February 18, 2019

Study information

• Verified date: October 2021
• Source: CMC Ambroise Paré
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: February 18, 2019
• Est. primary completion date: February 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• 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.

Drug:
• Propofol
The dosage is modified automatically by the device or according to the new medical prescription.
• Remifentanil
The dosage is modified automatically by the device or according to the new medical prescription.

Locations

Country	Name	City	State
France	Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon	Besançon	Bourgogne-Franche-Comté
France	Service d'Anesthésie du Centre Clinical	Soyaux	Poitou-Charentes
France	Service d'Anesthésie, Hôpital Foch	Suresnes	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

References & Publications (2)

Jensen EW, Valencia JF, López A, Anglada T, Agustí 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( — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Adequate analgesia	Percentage of time with qNox index within the 40-60 range as recommended by the manufacturer of Conox monitor.	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
Secondary	Occurrence of Burst Suppression Ratio (bsr)	Presence of Burst Suppression defined by a rate > 10% for at least one minute	Intraoperative period
Secondary	Dose of hypnotic drug	Total amount of propofol during the induction and the maintenance of the anesthesia	Intraoperative period
Secondary	Dose of analgesic drug	Total amount of remifentanil during the induction and the maintenance of the anesthesia	Intraoperative period
Secondary	Medical interventions on the dosage of drugs	Number of modifications of target of propofol and remifentanil	Intraoperative period
Secondary	Hemodynamic status	Number of episodes of hemodynamic anomalies having required a treatment	Intraoperative period
Secondary	Fluid therapy	Intraoperative volume loading and transfusion	Intraoperative period
Secondary	Delay before awakening	Delay between the cessation of infusion of propofol and remifentanil and extubation	12 hours
Secondary	Explicit memorization	Awareness standardized questionnaire	48 hours