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

Hewson, David W; Worcester, Frank; Sprinks, James; Smith, Murray D; Buchanan, Heather; Breedon, Philip; Hardman, Jonathan G; Bedforth, Nigel M

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.

Citation

Hewson, D. W., Worcester, F., Sprinks, J., Smith, M. D., Buchanan, H., Breedon, P., Hardman, J. G., & Bedforth, N. M. (2022). Patient-maintained versus anaesthetist-controlled propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia: a randomised controlled trial. British Journal of Anaesthesia, 128(1), 186-197. https://doi.org/10.1016/j.bja.2021.09.038

• Journal Article Type: Article
• Acceptance Date: Sep 5, 2021
• Online Publication Date: Dec 21, 2021
• Publication Date: 2022-01
• Deposit Date: May 29, 2025
• Publicly Available Date: Jun 2, 2025
• Journal: British Journal of Anaesthesia
• Print ISSN: 0007-0912
• Electronic ISSN: 1471-6771
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 128
• Issue: 1
• Pages: 186-197
• DOI: https://doi.org/10.1016/j.bja.2021.09.038
• Keywords: anxiolytic agents, arthroplasty, conscious sedation, patient satisfaction, propofol, sedation, target-controlled infusion
• Public URL: https://nottingham-repository.worktribe.com/output/49558128
• Publisher URL: https://www.sciencedirect.com/science/article/pii/S0007091221006516?via%3Dihub