Design and implementation of a closed-loop control system for infusion of propofol guided by bispectral index (BIS).

BACKGROUND: This study describes the design of a hypnosis closed-loop control system with propofol. The controller used a proportional-integral (PI) algorithm with the bispectral index (BIS) as the feedback signal. Our hypothesis was that a PI closed-loop control could be applied in clinical practice safely keeping the BIS within a pre-determined target range.

METHODS: The adjustment of the PI parameters was based on simulation. The procedure had three steps: obtaining a patient model using data from 12 patients, designing and adjusting the controller in simulation, and fine tuning the PI parameters in a pilot study (10 patients). The resulting controller was tested in 24 American Society of Anesthesiology (ASA) I-II patients. The controller directly decides the infusion rate of propofol, and no model is necessary in its online operation. The BIS target was set to 50. Remifentanil was used for analgesia.

RESULTS: We evaluated the efficiency and safety of the automatic feedback system. It worked properly in all the patients. The median performance error was -1.62, and the median absolute performance error was 11.03. Average propofol-normalized consumption was 5.3 ± 1.8 mg/kg/h. Mean percentage of BIS in the range 40-60 was 83%. Mean time to open eyes was 8 ± 4 min. Time to extubation was 9 ± 5 min. Hemodynamic adverse event or intraoperative awareness were not recorded.

CONCLUSIONS: The closed-loop system was able to maintain the BIS within an acceptable range of levels. The control of a propofol infusion guided by the BIS is feasible without hemodynamic instability in ASA I/II patients.