Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial

Hewson, David W. and Worcester, Frank and Sprinks, James and Smith, Murray D. and Buchanan, Heather and Breedon, Philip and Hardman, Jonathan G. and Bedforth, Nigel M. (2019) Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial. Trials, 20 (1). ISSN 1745-6215

Full content URL: http://doi.org/10.1186/s13063-019-3228-4

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Anaesthetist-controlled versus patient-maintained effect-site targeted propofol sedation during elective primary lower-limb arthroplasty performed under spinal anaesthesia (ACCEPTS): study protocol for a parallel-group randomised comparison trial
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Abstract

Background: The clinical efficacy of effect-site targeted patient-maintained propofol sedation (PMPS) compared to
anaesthetist-controlled propofol sedation (ACPS) for patients undergoing awake joint replacement surgery is
currently unknown. There is no commercially available medical device capable of delivering PMPS so we have
designed and built such a device. We plan a clinical trial to compare PMPS to ACPS and to collect data relating to
the safety of our prototype device in delivering sedation.
Methods: The trial is an open-label, randomised, controlled superiority trial recruiting adults who are undergoing
elective primary lower-limb arthroplasty with sedation by propofol infusion by effect-site targeting into two
equal-sized parallel arms: PMPS and ACPS. The primary research objective is to compare the body-weight-normalised
rate of propofol consumption when sedation for surgery on adults undergoing elective primary lower-limb arthroplasty
under spinal anaesthesia is patient-maintained versus when it is anaesthetist-controlled. The study primary null
hypothesis is that there is no difference in the rate of propofol consumption when sedation is patient-maintained
versus anaesthetist-controlled.
Discussion: This is the first trial to test the superiority of effect-site-targeted patient-maintained propofol sedation
versus anaesthetist-controlled propofol sedation in terms of total propofol consumption during the sedation period.
The results of this trial will help inform clinicians and device manufacturers of the clinical efficacy and safety of
patient-maintained propofol sedation applied to a common operative setting.
Trial registration: International Standard Randomised Controlled Trial Number Registry, ISRCTN29129799. Prospectively
registered on 12 June 2018.

Keywords:Propofol sedation, Patient-maintained propofol sedation, Regional anaesthesia, Joint athroplasty, Procedural sedation
Subjects:B Subjects allied to Medicine > B800 Medical Technology
A Medicine and Dentistry > A300 Clinical Medicine
Divisions:College of Social Science > School of Health & Social Care
ID Code:35007
Deposited On:10 Apr 2019 15:13

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