Automated Anesthesia Guided by the Conox Monitor for Surgery (Conox-loop)

CMC Ambroise Paré

Status: Terminated

Conditions: Anesthesia, General

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03540875

2017/04

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Full automation group

Experimental group

Description:

Full automation control of propofol and remifentanil

Treatment:

Drug: Propofol

Drug: Remifentanil

Device: Closed loop anesthesia

Control group

Other group

Description:

Manual control of of propofol and remifentanil using TCI system

Treatment:

Drug: Propofol

Drug: Remifentanil