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. 2023 Oct 19;12(20):6611.
doi: 10.3390/jcm12206611.

Anesthesia Management via an Automated Control System for Propofol, Remifentanil, and Rocuronium Compared to Management by Anesthesiologists: An Investigator-Initiated Study

Osamu Nagata  1 , Yuka Matsuki  1 , Shuko Matsuda  1 , Keita Hazama  2 , Saiko Fukunaga  3 , Hideki Nakatsuka  3 , Fumiyo Yasuma  4 , Yasuhiro Maehara  4 , Shoko Fujioka  5 , Karin Tajima  5 , Ichiro Kondo  5 , Itaru Ginoza  6 , Misuzu Hayashi  6 , Manabu Kakinohana  6 , Kenji Shigemi  1
Affiliations

Anesthesia Management via an Automated Control System for Propofol, Remifentanil, and Rocuronium Compared to Management by Anesthesiologists: An Investigator-Initiated Study

Osamu Nagata et al. J Clin Med. .

Abstract

Background: We previously developed an automated total intravenous anesthesia control system that uses new closed-loop system algorithms to administer propofol, remifentanil, and rocuronium based on the bispectral index and train-of-four data. We recently improved this automated control system by adding a safety mechanism and using a modified monitoring device.

Methods: Patients scheduled for elective surgery were randomly assigned to closed-loop feedback control (automatic group) or the manual administration of propofol, remifentanil, and rocuronium (manual group). The proportion of time during which the proper management of three-agent anesthesia was maintained during surgery was determined as the primary endpoint.

Results: The proportion of time during which the three components of sedation, analgesia, and muscle relaxation were adequately controlled was 87.21 ± 12.79% in the automatic group, which was non-inferior to the proportion of 65.19 ± 20.16% in the manual group (p < 0.001). Adverse events during the operative or postoperative observation periods were significantly less frequent in the automatic group (54 patients, 90.0%) than in the manual group (60 patients, 100.0%; p = 0.027).

Conclusion: Our three-agent automated control system, which features an improved muscle relaxation monitor and safety mechanism added to the basic control algorithms, maintained sedation, analgesia, and muscle relaxation appropriately in a manner non-inferior to anesthesiologists without compromising safety.

Keywords: anesthesia; automated control system; closed-loop control; propofol; remifentanil; rocuronium.

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Conflict of interest statement

The authors disclose that the Nihon Kohden Corporation (NKC) provided control software in accordance with the Clinical Trials Act in Japan. The NKC received funding as a joint research partner from AMED to cover the development of the control software.

Figures

Figure 1
Figure 1
Definition of insufficient analgesia.
Figure 2
Figure 2
Definition of adequate anesthesia time.
Figure 3
Figure 3
Flowchart of patient inclusion in the study.
Figure 4
Figure 4
Bispectral index (BIS) values, systolic blood pressure (BP), heart rate (HR), and effect-site concentrations of propofol (Ce of propofol), remifentanil (Ce of remi), and rocuronium (Ce of Rb) for 2 h from the start of surgery. Data are given as median values with 10th and 90th percentiles.
See this image and copyright information in PMC

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