Automated Anesthesia Guided by the Conox Monitor for Surgery
- Conditions
- Anesthesia, General
- Interventions
- Registration Number
- NCT03540875
- Lead Sponsor
- CMC Ambroise Paré
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 62
- Scheduled surgery for at least one hour
- Consent for participation
- Affiliation to the social security system
- Pregnant or breastfeeding women
- Patients for which Conox monitor should not be used
- Allergies to propofol or remifentanil
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Full automation group Remifentanil Full automation control of propofol and remifentanil Control group Propofol Manual control of of propofol and remifentanil using TCI system Control group Remifentanil Manual control of of propofol and remifentanil using TCI system Full automation group Closed loop anesthesia Full automation control of propofol and remifentanil Full automation group Propofol Full automation control of propofol and remifentanil
- Primary Outcome Measures
Name Time Method 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
Name Time Method Dose of analgesic drug Intraoperative period Total amount of remifentanil during the induction and the maintenance of the anesthesia
Explicit memorization 48 hours Awareness standardized questionnaire
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
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
Trial Locations
- Locations (3)
Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon
🇫🇷Besançon, Bourgogne-Franche-Comté, France
Service d'Anesthésie, Hôpital Foch
🇫🇷Suresnes, Ile De France, France
Service d'Anesthésie du Centre Clinical
🇫🇷Soyaux, Poitou-Charentes, France
Service d'Anesthésie Réanimation Chirurgicale, CHU Besançon🇫🇷Besançon, Bourgogne-Franche-Comté, France