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Randomized Controlled Trial
. 2022 Jan;128(1):186-197.
doi: 10.1016/j.bja.2021.09.038. Epub 2021 Nov 28.

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

David W Hewson  1 , Frank Worcester  2 , James Sprinks  2 , Murray D Smith  3 , Heather Buchanan  4 , Philip Breedon  2 , Jonathan G Hardman  5 , Nigel M Bedforth  6
Affiliations
Randomized Controlled Trial

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

David W Hewson et al. Br J Anaesth. 2022 Jan.

Abstract

Background: Patient-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.

Methods: In 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).

Results: Eighty 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).

Conclusions: Patient-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 registration: ISRCTN29129799.

Keywords: anxiolytic agents; arthroplasty; conscious sedation; patient satisfaction; propofol; sedation; target-controlled infusion.

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Figures

Fig 1
Fig 1
Consolidated Standards of Reporting Trials (CONSORT) flow diagram of trial participants. ACPS, anaesthetist-controlled propofol sedation; PMPS, patient-maintained propofol sedation.
Fig 2
Fig 2
Calculated effect-site concentrations (Cet) of propofol over time. (a) Subjects who received ACPS (note single outlier administered peak Cet of 5.0 μg ml−1 removed). (b) Subjects who received PMPS who made one or two demands to increment their sedation. (c) Subjects who received PMPS who made three or more demands to increment their sedation. In all plots, the Cet during sedation is represented as a solid line, and the Cet after the discontinuation of sedation is represented by a dashed line. In (b) and (c), successful button activations are represented by solid coloured circles. ACPS, anaesthetist-controlled propofol sedation; PMPS, patient-maintained propofol sedation.
Fig 3
Fig 3
Patient-reported outcome measures. ACPS, anaesthetist-controlled propofol sedation; PMPS, patient-maintained propofol sedation.
See this image and copyright information in PMC

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