Technical and clinical evaluation of a closed loop TIVA system with SEDLineTM spectral density monitoring: Multicentric prospective cohort study

Abstract

Introduction: Closed loop total intravenous anesthesia is a technique in which the patient's hemodynamic and anesthetic depth variables are monitored, and based on this information, a computer controls the infusion rate of drugs to keep them within pre-established clinical parameters. Objective: To describe the technical and clinical performance of a closed loop system for total intravenous anesthesia with propofol and remifentanil, using the SEDLine TM monitor Design: Multicentric prospective cohort study Setting: Surgery room Patients: ASA I-II undergoing elective surgery Measurements: The authors designed a closed loop system that implements a control algorithm based on anesthetic depth monitoring and the Patient State Index (PSI TM ) of the SEDLine monitor for propofol, and on hemodynamic variables for remifentanil. The measurement of clinical performance was made based on the percentage of PSI TM maintenance time in the range 20-50. Precision analysis was evaluated by measuring median performance error (MDPE) can be defined as the median difference between actual and desired values, which refers to the degree of precision in which the controller is able to maintain the control variable within the objective set by the anesthesiologist; it represents the direction (over-prediction or underprediction) of performance error (PE) rather than size of errors, which is represented by MDAPE, median absolute percentage error, Wobble index, which is used for measuring the intrasubject variability in performance error. Results: Data were obtained from 93 patients in three healthcare centers. The percentage of PSI TM maintenance time in the 20-50 range was 92% (80.7-97.0). MDPE was 10.7 (− 11.0-18.0), MDAPE 21.0 (14.2-26.8) and wobble 10.7 (7.0-16.9). No adverse surgical or anesthetic events were found.

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“…[ 14 ] A recent publication (2020) by Castellanos Peñaranda et al . [ 15 ] presented a closed-loop designed for total intravenous anesthesia integrated with an anesthesia depth monitor (SEDLine, Masimo, Irvin, USA).…”

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“…The algorithms use a rule-base system to decide if remifentanil infusion is changed, or remifentanil and propofol infusions. Casas-Arroyave et al 38 presented a dual controller incorporating BIS, heart rate, and blood pressure—the latter parameters combined using the “Analgoscore.” 41,42 They used the patient state index as a clinical control feedback variable for propofol infusion, and the “Analgoscore” for control feedback of remifentanil infusion. Moreover, they extracted several parameters out of the patient state index, such as EMG signals, suppression rates, and spectral edge frequencies, as part of the control feedback for the propofol infusion.…”

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“…Both can be used to monitor anesthetic depth trends in the Sleep-Awake-Sleep phase, to achieve an early and gentle awakening of total intravenous anesthesia [24]. The use of processed electroencephalography indices improves anesthetic titration in the intraoperative period.…”

“…PSi values can range from 0 to 100; higher values indicate a lower degree of sedation as follows: 0-24 outbreak suppression with varying degrees of suppression, 25-49 general anesthesia, and > 50 mild sedation [23]. The algorithm uses specific frequency band performance power combined with symmetry and synchronization changes in multiple cortical regions [24]. Without a doubt, processed EEG systems are an excellent tool to optimize sedation and plan proper awakening in awake craniotomy.…”