Automated Anesthesia Guided by the Conox Monitor for Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anesthesia, General

Intervention / Treatment
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* Device: Closed loop anesthesia
* Drug: Propofol
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full automation group<br>Full automation control of propofol and remifentanil | Device: Closed loop anesthesia<br>* 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.<br>Drug: Propofol<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>Drug: Remifentanil<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>|
| Other: Control group<br>Manual control of of propofol and remifentanil using TCI system | Drug: Propofol<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>Drug: Remifentanil<br>* The dosage is modified automatically by the device or according to the new medical prescription.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Occurrence of Burst Suppression Ratio (bsr) | Presence of Burst Suppression defined by a rate > 10% for at least one minute | Intraoperative period | 
| Dose of hypnotic drug | Total amount of propofol during the induction and the maintenance of the anesthesia | Intraoperative period | 
| Dose of analgesic drug | Total amount of remifentanil during the induction and the maintenance of the anesthesia | Intraoperative period | 
| Medical interventions on the dosage of drugs | Number of modifications of target of propofol and remifentanil | Intraoperative period | 
| Hemodynamic status | Number of episodes of hemodynamic anomalies having required a treatment | Intraoperative period | 
| Fluid therapy | Intraoperative volume loading and transfusion | Intraoperative period | 
| Delay before awakening | Delay between the cessation of infusion of propofol and remifentanil and extubation | 12 hours | 
| Explicit memorization | Awareness standardized questionnaire | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthesia, general, Total intravenous anesthesia, Closed loop anesthesia, Conox, EEG monitoring, qCon, qNox