Anesthesia, General
Conditions
Brief summary
To compare manual administration of propofol and remifentanil and dual closed-loop using bispectral index as the control variable during anesthesia
Detailed description
The Bispectral Index (BIS) is an electroencephalogram-derived measure of anesthetic depth. A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, and a propofol target-controlled infusion system as the control actuator. Recent studies have shown that such system is able to provide clinically adequate anesthesia. We hypothesized that BIS can also indicate the adequacy of analgesia and therefore built a combined closed-loop anesthesia system using BIS as the control variable, two proportional-integral-differential control algorithms, a propofol and a remifentanil target-controlled infusion systems as the control actuators. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain BIS between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.
Interventions
Sponsors
Hopital Foch
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* surgery under general anesthesia using relaxant agent, * surgery lasting more than one hour
Exclusion criteria
* pregnant women, * indication for rapid sequence induction, * anticipation of difficult intubation, * allergy to propofol or remifentanil, * neurological or muscular disorder, * combination of general anesthesia and of regional anesthesia, * emergency surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range) | — |
Secondary
| Measure | Time frame |
|---|---|
| number of modifications of target of propofol and remifentanil | — |
| number of episodes of hemodynamic anomalies having required a treatment | — |
| consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia | — |
| extubation time, explicit memorisation | — |
| dysfunctions of each system | — |
| intraoperative volume loading and transfusion | — |
Countries
France
Outcome results
None listed