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A novel system for automated propofol sedation: hybrid sedation system (HSS)

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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.

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Acknowledgments

This study was supported by a grant from the NSERC-CHRP.

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Authors and Affiliations

  1. Department of Cardiac Anaesthesia and Cardiac Intensive Care, Service d’Anesthésie-Réanimation II, CHU Bordeaux, Avenue de Magellan, Pessac, 33604, France

    Cedrick Zaouter

  2. Department of Anaesthesia and Intensive Care, University of Pisa, Pisa, Italy

    Riccardo Taddei, Erik Arbeid & Francesco Giunta

  3. Department of Anaesthesia, McGill University, Montreal, Canada

    Mohamad Wehbe, Shantale Cyr & Thomas M. Hemmerling

Authors
  1. Cedrick Zaouter
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  2. Riccardo Taddei
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  3. Mohamad Wehbe
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  4. Erik Arbeid
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  5. Shantale Cyr
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  6. Francesco Giunta
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  7. Thomas M. Hemmerling
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Corresponding author

Correspondence to Cedrick Zaouter.

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Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standard

This report describes human research. IRB contact information: Research Ethics Board (REB), McGill University.

Informed consent

This study was conducted with written informed consent from the study subjects.

Additional information

This report describes a prospective randomized clinical trial. The author states that the report includes every item in the CONSORT checklist for a prospective randomized clinical trial. This was not an observational clinical study.

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Zaouter, C., Taddei, R., Wehbe, M. et al. A novel system for automated propofol sedation: hybrid sedation system (HSS). J Clin Monit Comput 31, 309–317 (2017). https://doi.org/10.1007/s10877-016-9858-0

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  • DOI: https://doi.org/10.1007/s10877-016-9858-0

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