Conox-loop: Automated Anesthesia Guided by the Conox Monitor for Surgery

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Terminated

CT.gov ID

NCT03540875

Collaborator

(none)

Enrollment

Locations

Arms

7.6

Actual Duration (Months)

20.7

Patients Per Site

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General	Device: Closed loop anesthesia Drug: Propofol Drug: Remifentanil	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 2, 2018

Actual Primary Completion Date :

Feb 18, 2019

Actual Study Completion Date :

Feb 18, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Full automation group Full automation control of propofol and remifentanil	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.
Other: Control group Manual control of of propofol and remifentanil using TCI system	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.

Arm

Intervention/Treatment

Experimental: Full automation group

Full automation control of propofol and remifentanil

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.

Other: Control group

Manual control of of propofol and remifentanil using TCI system

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.

Outcome Measures

Primary Outcome Measures

Adequate sedation [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]
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon	Besançon	Bourgogne-Franche-Comté	France	25030
2	Service d'Anesthésie, Hôpital Foch	Suresnes	Ile De France	France	92151
3	Service d'Anesthésie du Centre Clinical	Soyaux	Poitou-Charentes	France	16800