• Br J Anaesth · Jan 2022

    Randomized Controlled Trial Comparative Study

    Patient-maintained versus anaesthetist-controlled propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia: a randomised controlled trial.

    • David W Hewson, Frank Worcester, James Sprinks, Murray D Smith, Heather Buchanan, Philip Breedon, Jonathan G Hardman, and Nigel M Bedforth.
    • Department of Anaesthesia and Critical Care Medicine, Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK. Electronic address: david.hewson@nottingham.ac.uk.
    • Br J Anaesth. 2022 Jan 1; 128 (1): 186197186-197.

    BackgroundPatient-maintained propofol TCI sedation (PMPS) allows patients to titrate their own target-controlled infusion (TCI) delivery of propofol sedation using a handheld button. The aim of this RCT was to compare PMPS with anaesthetist-controlled propofol TCI sedation (ACPS) in patients undergoing elective primary lower-limb arthroplasty surgery under spinal anaesthesia.MethodsIn this single-centre open-label investigator-led study, adult patients were randomly assigned to either PMPS or ACPS during their surgery. Both sedation regimes used Schnider effect-site TCI modelling. The primary outcome measure was infusion rate adjusted for weight (expressed as mg kg-1 h-1). Secondary outcomes measures included depth of sedation, occurrence of sedation-related adverse events and time to medical readiness for discharge from the postanaesthsia care unit (PACU).ResultsEighty patients (48 female) were randomised. Subjects using PMPS used 39.3% less propofol during the sedation period compared with subjects in group ACPS (1.56 [0.57] vs 2.57 [1.33] mg kg-1 h-1; P<0.001), experienced fewer discrete episodes of deep sedation (0 vs 6; P=0.0256), fewer airway/breathing adverse events (odds ratio [95% confidence interval]: 2.94 [1.31-6.64]; P=0.009) and were ready for discharge from PACU more quickly (8.94 [5.5] vs 13.51 [7.2] min; P=0.0027).ConclusionsPatient-maintained propofol sedation during lower-limb arthroplasty under spinal anaesthesia results in reduced drug exposure and fewer episodes of sedation-related adverse events compared with anaesthetist-controlled propofol TCI sedation. To facilitate further investigation of this procedural sedation technique, PMPS-capable TCI infusion devices should be submitted for regulatory approval for clinical use.Clinical Trial RegistrationISRCTN29129799.Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

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