Clinical trial NCT03540875: Automated Anesthesia Guided by the Conox Monitor for Surgery
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia, General
Keywords: Anesthesia, general
Total intravenous anesthesia
Closed loop anesthesia
Conox
EEG monitoring
qCon
qNox
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adequate sedation
timeFrame: 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 outcomes:
measure: Adequate analgesia
timeFrame: 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
measure: Occurrence of Burst Suppression Ratio (bsr)
timeFrame: Intraoperative period
measure: Dose of hypnotic drug
timeFrame: Intraoperative period
measure: Dose of analgesic drug
timeFrame: Intraoperative period
measure: Medical interventions on the dosage of drugs
timeFrame: Intraoperative period
measure: Hemodynamic status
timeFrame: Intraoperative period
measure: Fluid therapy
timeFrame: Intraoperative period
measure: Delay before awakening
timeFrame: 12 hours
measure: Explicit memorization
timeFrame: 48 hours
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon
state: Bourgogne-Franche-Comté
city: Suresnes
country: France
facility: Service d'Anesthésie, Hôpital Foch
state: Ile De France
city: Soyaux
country: France
facility: Service d'Anesthésie du Centre Clinical
state: Poitou-Charentes
Study officials:
affiliation: Hôpital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
References:
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 Mar;112(3):546-57. doi: 10.1213/ANE.0b013e318205680b. Epub 2011 Jan 13.
citation: Jensen EW, Valencia JF, Lopez A, Anglada T, Agusti 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(8):933-41. doi: 10.1111/aas.12359. Epub 2014 Jul 4.