Anesthesia, General
Conditions
Keywords
Anesthesia, general, Total intravenous anesthesia, Closed loop anesthesia, Conox, EEG monitoring, qCon, qNox
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.
Interventions
DEVICEClosed 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.
DRUGPropofol
The dosage is modified automatically by the device or according to the new medical prescription.
DRUGRemifentanil
The dosage is modified automatically by the device or according to the new medical prescription.
Sponsors
CMC Ambroise Paré
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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 |
| Hemodynamic status | Intraoperative period | Number of episodes of hemodynamic anomalies having required a treatment |
Countries
France
Outcome results
None listed