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Tytuł:
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Design and Evaluation of a Closed-Loop Anesthesia System With Robust Control and Safety System.
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Autorzy:
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West N; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.
van Heusden K; Electrical and Computer Engineering, University of British Columbia, Vancouver, British Columbia, Canada.
Görges M; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.; Research Institute, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
Brodie S; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.
Rollinson A; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.
Petersen CL; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.
Dumont GA; Electrical and Computer Engineering, University of British Columbia, Vancouver, British Columbia, Canada.; Research Institute, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
Ansermino JM; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.; Research Institute, British Columbia Children's Hospital, Vancouver, British Columbia, Canada.
Merchant RN; From the Departments of Anesthesiology, Pharmacology, and Therapeutics.; Department of Anesthesia, Royal Columbian Hospital, Fraser Health Authority, New Westminster, British Columbia, Canada.
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Źródło:
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Anesthesia and analgesia [Anesth Analg] 2018 Oct; Vol. 127 (4), pp. 883-894.
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Typ publikacji:
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Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
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Język:
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English
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Imprint Name(s):
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Publication: 1998- : Baltimore, Md. : Lippincott Williams & Wilkins
Original Publication: Cleveland, International Anesthesia Research Society.
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MeSH Terms:
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Infusion Pumps*/adverse effects
Analgesics, Opioid/*administration & dosage
Anesthesia, Intravenous/*instrumentation
Anesthetics, Intravenous/*administration & dosage
Consciousness/*drug effects
Drug Delivery Systems/*instrumentation
Electroencephalography/*instrumentation
Intraoperative Neurophysiological Monitoring/*instrumentation
Propofol/*administration & dosage
Remifentanil/*administration & dosage
Adult ; Aged ; Aged, 80 and over ; Analgesics, Opioid/adverse effects ; Anesthesia, Intravenous/adverse effects ; Anesthetics, Intravenous/adverse effects ; Drug Delivery Systems/adverse effects ; Equipment Design ; Feasibility Studies ; Female ; Hemodynamics/drug effects ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Patient Safety ; Predictive Value of Tests ; Propofol/adverse effects ; Remifentanil/adverse effects ; Risk Factors ; Wavelet Analysis ; Young Adult
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Grant Information:
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Canada CIHR
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Molecular Sequence:
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ClinicalTrials.gov NCT01771263
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Substance Nomenclature:
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0 (Analgesics, Opioid)
0 (Anesthetics, Intravenous)
P10582JYYK (Remifentanil)
YI7VU623SF (Propofol)
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Entry Date(s):
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Date Created: 20171207 Date Completed: 20190819 Latest Revision: 20190819
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Update Code:
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20240105
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DOI:
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10.1213/ANE.0000000000002663
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PMID:
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29210791
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Background: Closed-loop control of anesthesia involves continual adjustment of drug infusion rates according to measured clinical effect. The NeuroSENSE monitor provides an electroencephalographic measure of depth of hypnosis (wavelet-based anesthetic value for central nervous system monitoring [WAVCNS]). It has previously been used as feedback for closed-loop control of propofol, in a system designed using robust control engineering principles, which implements features specifically designed to ensure patient safety. Closed-loop control of a second drug, remifentanil, may be added to improve WAVCNS stability in the presence of variable surgical stimulation. The objective of this study was to design and evaluate the feasibility of a closed-loop system for robust control of propofol and remifentanil infusions using WAVCNS feedback, with an infusion safety system based on the known pharmacological characteristics of these 2 drugs.
Methods: With Health Canada authorization, research ethics board approval, and informed consent, American Society of Anesthesiologists I-III adults, requiring general anesthesia for elective surgery, were enrolled in a 2-phase study. In both phases, infusion of propofol was controlled in closed loop during induction and maintenance of anesthesia, using WAVCNS feedback, but bounded by upper- and lower-estimated effect-site concentration limits. In phase I, remifentanil was administered using an adjustable target-controlled infusion and a controller was designed based on the collected data. In phase II, remifentanil was automatically titrated to counteract rapid increases in WAVCNS.
Results: Data were analyzed for 127 patients, of median (range) age 64 (22-86) years, undergoing surgical procedures lasting 105 (9-348) minutes, with 52 participating in phase I and 75 in phase II. The overall control performance indicator, global score, was a median (interquartile range) 18.3 (14.2-27.7) in phase I and 14.6 (11.6-20.7) in phase II (median difference, -3.25; 95% confidence interval, -6.35 to -0.52). The WAVCNS was within ±10 of the setpoint for 84.3% (76.6-90.6) of the maintenance of anesthesia in phase I and 88.2% (83.1-93.4) in phase II (median difference, 3.7; 95% confidence interval, 0.1-6.9). The lower propofol safety bound was activated during 30 of 52 (58%) cases in phase I and 51 of 75 (68%) cases in phase II.
Conclusions: Adding closed-loop control of remifentanil improved overall controller performance. This controller design offers a robust method to optimize the control of 2 drugs using a single sensor. The infusion safety system is an important component of a robust automated anesthesia system, but further research is required to determine the optimal constraints for these safe conditions.