NCT03540875

Automated Anesthesia Guided by the Conox Monitor for Surgery

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
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.
DRUG	Remifentanil	The dosage is modified automatically by the device or according to the new medical prescription.

Timeline

• Start date: 2018-07-02
• Primary completion: 2019-02-18
• Completion: 2019-02-18
• First posted: 2018-05-30
• Last updated: 2021-11-05

Locations

3 sites across 1 country: France