drugset / Trial / NCT03073408

Design of a Closed-loop Controller Based on the Bispectral Index (BIS) Effectiveness of the Smith Predictor

NCT03073408 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

The action of anesthetics such as propofol is not immediate after intravenous administration. Delay in pharmacodynamic effect of intravenous drugs is a commonly observed phenomenon in total intravenous anesthesia (TIVA). On the other hand, the measure of the clinical effect of propofol by EEG processed monitors like the bispectral index (BIS) also requires some processing time for the analysis of the recorded signal. Thus, the resulting BIS value provided by the monitor is affected by a delay. When a BIS based controller is used, the propofol infusion rates are defined using information of the BIS signal available. The delay in the BIS signal is an important issue as it can affect the performance of the controller. There are scarce contributions to address the delay in automatic administration of anesthesia. Our proposal to deal with the dead time in the control action of the hypnotic component of anesthesia is a proportional-integral (PI) algorithm with a Smith predictor. The aim of this study is to evaluate and compare the feasibility and effectiveness of a closed-loop control using the Smith predictor versus manual control for propofol administration guided by the bispectral index (BIS) in adults patients. The objective is to show that a closed loop control can be a useful tool to provide safe and effective intravenous anesthesia and that the use of specific controller for delay rejection is a reliable strategy.

Timeline

Start
2017-03-06
Primary completion
2017-09-15
Completion
2017-09-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Propofol Small molecule — Intravenous

Indications

No indication recorded.