Development of a patient-maintained sedation device to allow patients to safely control their own sedation levels during surgical and medical procedures (ACCEPTS)

PROJECT TITLE DEVELOPMENT OF A PATIENT-MAINTAINED SEDATION DEVICE TO ALLOW PATIENTS TO SAFELY CONTROL THEIR OWN SEDATION LEVELS DURING SURGICAL AND MEDICAL PROCEDURES (ACCEPTS)
Funding body National Institute for Health Research, Invention for Innovation (NIHR I4I), II-LA-0716-20002
Total funding £680,097
Team
  • Dr Nigel Bedforth* (principal investigator), Nottingham University Hospitals NHS Trust (NUH)
  • Mrs Susan Bowler, University of Lincoln
  • Dr David Hewson, Nottingham University Hospitals NHS Trust
  • Prof Philip Breedon, Nottingham Trent University
  • Dr Heather Buchanan, University of Nottingham
  • Dr Roy Harris, Nottingham University Hospitals NHS Trust
  • Prof Jonathan Hardman, University of Nottingham
  • Dr Adrian Manhire, Nottingham University Hospitals NHS Trust
  • Dr Murray D Smith, University of Lincoln
  • Dr James Sprinks, Nottingham Trent University
  • Mr Frank Worcester, Nottingham Trent University
Consortium
  • University of Lincoln
  • Nottingham University Hospitals NHS Trust
  • University of Nottingham
  • Nottingham Trent University
Overarching aim To build and test a sedation device that enables patients to control their own sedation level during surgery while awake.
Objectives

 
  • Design and build a handheld device for patient use during surgery awake
  • Develop hardware and software to enable and monitor target-infused propofol sedation in standard care NHS surgical infusion CE-marked device
  • Conduct the ACCEPTS randomised clinical trial to test use of patient-maintained sedation in knee replacement and hip replacement surgeries awake (ISRCTN 29129799)
  • Evaluation of costs and benefits if the sedation device is introduced into NHS practice
Methods University of Lincoln contribution:

  • Prepare ACCEPTS trial materials, database, randomisation schedule
  • Conduct statistical analyses of ACCEPTS data
  • Conduct economic valuation of invented technology
Outcomes

 

 Patient maintained propofol sedation (PMPS) during lower limb arthroplasty under spinal anaesthesia resulted in reduced drug exposure and fewer episodes of sedation related adverse events compared to standard care anaesthetist controlled propofol sedation. To facilitate further investigation of this procedural sedation technique, PMPS-capable TCI infusion devices should be submitted for regulatory approval for clinical use.
Outputs

 

 Publications

  • Hewson DW, Worcester F, Sprinks J, Smith MD, Buchanan H, Breedon P, Hardman JG, Bedforth NM. “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, February 2019, 20:129 (doi: 10.1186/s13063-019-3228-4)
  • Hewson DW, Worcester F, Sprinks J, Smith MD, Buchanan H, Breedon P, Hardman JG, Bedforth NM. “Patient-maintained versus anaesthetist-controlled propofol sedation during elective primary lower limb arthroplasty performed under spinal anaesthesia: a randomised controlled trial.” Forthcoming in British Journal of Anaesthesia
Impact The study provides the initial evidence for benefits of patient maintained sedation during surgery.