title: A novel system for automated propofol sedation: hybrid sedation system (HSS).
abstract: Closed-loop systems for propofol have been demonstrated to be safe and reliable for general anesthesia. However, no study has been conducted using a closed-loop system specifically designed for sedation in patients under spinal anesthesia. We developed an automatic anesthesia sedation system that allows for closed-loop delivery of propofol for sedation integrating a decision support system, called the hybrid sedation system (HSS). The objective of this study is to compare this system with standard practice. One hundred fifty patients were enrolled and randomly assigned to two groups: HSS-Group (N = 75), in which propofol was administered using a closed-loop system; Control Group (N = 75), in which propofol was delivered manually. The clinical performance of the propofol sedation control is defined as efficacy to maintain bispectral index (BIS) near 65. The clinical control was called 'Excellent', 'Good', 'Poor' and 'Inadequate' with BIS values within 10 %, from 11 to 20 %, 21 to 30 %, or greater than 30 % of the BIS target of 65, respectively. The controller performance was evaluated using Varvel's parameters. Data are presented as mean ± standard deviation, groups were compared using t test or Chi square test, P < 0.05. Clinical performance of sedation showed 'Excellent' control in the HSS-group for a significantly longer period of time (49 vs. 26 % in the control group, P < 0.0001). 'Poor' and 'Inadequate' sedation was significantly shorter in the HSS Group compared to the Control Group (11 and 10 % vs. 20 and 18 %, respectively, P < 0.0001). The novel, closed-loop system for propofol sedation showed better maintenance of the target BIS value compared to manual administration.
authors.affiliation: Department of Cardiac Anaesthesia and Cardiac Intensive Care, Service d'Anesthésie-Réanimation II, CHU Bordeaux, Avenue de Magellan, Pessac, 33604, France. cedrick.zaouter@gmail.com.
authors.forename: Cedrick
authors.initials: C
authors.lastname: Zaouter
authors.affiliation: Department of Anaesthesia and Intensive Care, University of Pisa, Pisa, Italy.
authors.forename: Riccardo
authors.initials: R
authors.lastname: Taddei
authors.affiliation: Department of Anaesthesia, McGill University, Montreal, Canada.
authors.forename: Mohamad
authors.initials: M
authors.lastname: Wehbe
authors.affiliation: Department of Anaesthesia and Intensive Care, University of Pisa, Pisa, Italy.
authors.forename: Erik
authors.initials: E
authors.lastname: Arbeid
authors.affiliation: Department of Anaesthesia, McGill University, Montreal, Canada.
authors.forename: Shantale
authors.initials: S
authors.lastname: Cyr
authors.affiliation: Department of Anaesthesia and Intensive Care, University of Pisa, Pisa, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Giunta
authors.affiliation: Department of Anaesthesia, McGill University, Montreal, Canada.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Hemmerling
mesh_terms: D000368:Aged; D000764:Anesthesia, Closed-Circuit / Q000295:instrumentation*; D000768:Anesthesia, General / Q000295:instrumentation*; D000771:Anesthesia, Intravenous / Q000295:instrumentation*; D018686:Anesthetics, Intravenous; D001331:Automation; D016292:Procedural Sedation / Q000295:instrumentation / Q000379:methods; D020000:Decision Support Systems, Clinical; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D059035:Perioperative Period; D015742:Propofol / Q000008:administration & dosage*; D011446:Prospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D018686:Anesthetics, Intravenous; D015742:Propofol
keywords: Automated sedation; Closed-loop; Propofol