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
Overview
- Phase
- Not Applicable
- Intervention
- Closed loop anesthesia
- Conditions
- Anesthesia, General
- Sponsor
- CMC Ambroise Paré
- Enrollment
- 62
- Locations
- 3
- Primary Endpoint
- Adequate sedation
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
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
Arms & Interventions
Full automation group
Full automation control of propofol and remifentanil
Intervention: Closed loop anesthesia
Full automation group
Full automation control of propofol and remifentanil
Intervention: Propofol
Full automation group
Full automation control of propofol and remifentanil
Intervention: Remifentanil
Control group
Manual control of of propofol and remifentanil using TCI system
Intervention: Propofol
Control group
Manual control of of propofol and remifentanil using TCI system
Intervention: Remifentanil
Outcomes
Primary Outcomes
Adequate sedation
Time Frame: 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 Outcomes
- Dose of analgesic drug(Intraoperative period)
- Explicit memorization(48 hours)
- 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)
- Delay before awakening(12 hours)
- Occurrence of Burst Suppression Ratio (bsr)(Intraoperative period)
- Dose of hypnotic drug(Intraoperative period)
- Medical interventions on the dosage of drugs(Intraoperative period)
- Hemodynamic status(Intraoperative period)
- Fluid therapy(Intraoperative period)