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Tytuł pozycji:

The Effect of Low-Dose Intraoperative Ketamine on Closed-Loop-Controlled General Anesthesia: A Randomized Controlled Equivalence Trial.

Tytuł:
The Effect of Low-Dose Intraoperative Ketamine on Closed-Loop-Controlled General Anesthesia: A Randomized Controlled Equivalence Trial.
Autorzy:
Napoleone G; From the Departments of Anesthesiology, Pharmacology and Therapeutics.
van Heusden K; Electrical and Computer Engineering, University of British Columbia (UBC), Vancouver, British Columbia, Canada.; Research Institute, BC Children's Hospital, Vancouver, British Columbia, Canada.
Cooke E; From the Departments of Anesthesiology, Pharmacology and Therapeutics.; Research Institute, BC Children's Hospital, Vancouver, British Columbia, Canada.
West N; From the Departments of Anesthesiology, Pharmacology and Therapeutics.
Görges M; From the Departments of Anesthesiology, Pharmacology and Therapeutics.; Research Institute, BC Children's Hospital, Vancouver, British Columbia, Canada.
Dumont GA; Electrical and Computer Engineering, University of British Columbia (UBC), Vancouver, British Columbia, Canada.; Research Institute, BC Children's Hospital, Vancouver, British Columbia, Canada.
Ansermino JM; From the Departments of Anesthesiology, Pharmacology and Therapeutics.; Research Institute, BC 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.
Źródło:
Anesthesia and analgesia [Anesth Analg] 2021 Nov 01; Vol. 133 (5), pp. 1215-1224.
Typ publikacji:
Equivalence Trial; Journal Article; Research Support, U.S. Gov't, Non-P.H.S.
Język:
English
Imprint Name(s):
Publication: 1998- : Baltimore, Md. : Lippincott Williams & Wilkins
Original Publication: Cleveland, International Anesthesia Research Society.
MeSH Terms:
Anesthesia, Closed-Circuit*/adverse effects
Anesthesia, General*/adverse effects
Intraoperative Neurophysiological Monitoring*
Analgesics, Opioid/*administration & dosage
Anesthetics, Dissociative/*administration & dosage
Anesthetics, Intravenous/*administration & dosage
Ketamine/*administration & dosage
Propofol/*administration & dosage
Remifentanil/*administration & dosage
Adult ; Analgesics, Opioid/adverse effects ; Anesthetics, Dissociative/adverse effects ; Anesthetics, Intravenous/adverse effects ; British Columbia ; Double-Blind Method ; Electroencephalography ; Female ; Humans ; Ketamine/adverse effects ; Male ; Middle Aged ; Orthopedic Procedures ; Postoperative Complications/etiology ; Propofol/adverse effects ; Remifentanil/adverse effects ; Time Factors ; Treatment Outcome ; Young Adult
References:
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Substance Nomenclature:
0 (Analgesics, Opioid)
0 (Anesthetics, Dissociative)
0 (Anesthetics, Intravenous)
690G0D6V8H (Ketamine)
P10582JYYK (Remifentanil)
YI7VU623SF (Propofol)
Entry Date(s):
Date Created: 20210209 Date Completed: 20211122 Latest Revision: 20230721
Update Code:
20240104
DOI:
10.1213/ANE.0000000000005372
PMID:
33560659
Czasopismo naukowe
Background: Closed-loop control of propofol-remifentanil anesthesia using the processed electroencephalography depth-of-hypnosis index provided by the NeuroSENSE monitor (WAVCNS) has been previously described. The purpose of this placebo-controlled study was to evaluate the performance (percentage time within ±10 units of the setpoint during the maintenance of anesthesia) of a closed-loop propofol-remifentanil controller during induction and maintenance of anesthesia in the presence of a low dose of ketamine.
Methods: Following ethical approval and informed consent, American Society of Anesthesiologist (ASA) physical status I-II patients aged 19-54 years, scheduled for elective orthopedic surgery requiring general anesthesia for >60 minutes duration, were enrolled in a double-blind randomized, placebo-controlled, 2-group equivalence trial. Immediately before induction of anesthesia, participants in the ketamine group received a 0.25 mg·kg-1 bolus of intravenous ketamine over 60 seconds followed by a continuous 5 µg·kg-1·min-1 infusion for up to 45 minutes. Participants in the control group received an equivalent volume of normal saline. After the initial study drug bolus, closed-loop induction of anesthesia was initiated; propofol and remifentanil remained under closed-loop control until the anesthetic was tapered and turned off at the anesthesiologist's discretion. An equivalence range of ±8.99% was assumed for comparing controller performance.
Results: Sixty patients participated: 41 males, 54 ASA physical status I, with a median (interquartile range [IQR]) age of 29 [23, 38] years and weight of 82 [71, 93] kg. Complete data were available from 29 cases in the ketamine group and 27 in the control group. Percentage time within ±10 units of the WAVCNS setpoint was median [IQR] 86.6% [79.7, 90.2] in the ketamine group and 86.4% [76.5, 89.8] in the control group (median difference, 1.0%; 95% confidence interval [CI] -3.6 to 5.0). Mean propofol dose during maintenance of anesthesia for the ketamine group was higher than for the control group (median difference, 24.9 µg·kg-1·min-1; 95% CI, 6.5-43.1; P = .005).
Conclusions: Because the 95% CI of the difference in controller performance lies entirely within the a priori equivalence range, we infer that this analgesic dose of ketamine did not alter controller performance. Further study is required to confirm the finding that mean propofol dosing was higher in the ketamine group, and to investigate the implication that this dose of ketamine may have affected the WAVCNS.
Competing Interests: Conflicts of Interest: See Disclosures at the end of the article.
(Copyright © 2021 International Anesthesia Research Society.)

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