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Published in: Trials 1/2019

Open Access 01-12-2019 | Spinal Anesthesia | Study protocol

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

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

Published in: Trials | Issue 1/2019

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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.
Appendix
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Literature
1.
2.
Basques BA, Toy JO, Bohl DD, Golinvaux NS, Grauer JN. General compared with spinal anesthesia for total hip arthroplasty. J Bone Jt Surg. 2015;97:455–61.CrossRef
3.
Badner NH, Nielson WR, Munk S, Kwiatkowska C, Gelb AW. Preoperative anxiety: detection and contributing factors. Can J Anaesth. 1990;37:444–7.CrossRef
4.
Mitchell M. Patient anxiety and conscious surgery. J Perioper Pract. 2009;19:168.CrossRef
5.
Schnider T, Minto C. The influence of method of administration and covariates on the pharmacokinetics of propofol in adult volunteers. Anesthesiology. 1998;88:1170–82.CrossRef
6.
Fekrat F, Sahin A, Yazici K. Anaesthetists’ and surgeons’ estimation of preoperative anxiety by patients submitted for elective surgery in a university hospital. Eur J Anaesthesiol. 2006;23:227–33.CrossRef
7.
Murdoch JAC, Grant SA, Kenny GNC. Safety of patient-maintained propofol sedation using a target-controlled system in healthy volunteers. Br J Anaesth. 2000;85:299–316.CrossRef
8.
Irwin MG, Thompson N, Kenny GNC. Patient-maintained propofol sedation. Anaesthesia. 1997;52:525–30.CrossRef
9.
Chapman RM, Anderson K, Green J, Leitch JA, Gambhir S, Kenny GNC. Evaluation of a new effect-site controlled, patient-maintained sedation system in dental patients. Anaesthesia. 2006;61:345–9.CrossRef
10.
Campbell L, Imrie G, Doherty P, Porteous C, Millar K, Kenny GNC. Patient maintained sedation for colonoscopy using a target controlled infusion of propofol. Anaesthesia. 2004;59:127–32.CrossRef
11.
Rodrigo MRC, Irwin MG, Tong CKA, Yan SY. A randomised crossover comparison of patient-controlled sedation and patient-maintained sedation using propofol. Anaesthesia. 2003;58:333–8.CrossRef
12.
Leitch JA, Anderson K, Gambhir S, Millar K, Robb ND, McHugh S, et al. A partially blinded randomised controlled trial of patient-maintained propofol sedation and operator controlled midazolam sedation in third molar extractions. Anaesthesia. 2004;59:853–60.CrossRef
13.
Stonell CA, Leslie K, Absalom AR. Effect-site targeted patient-controlled sedation with propofol: comparison with anaesthetist administration for colonoscopy. Anaesthesia. 2006;61:240–7.CrossRef
14.
15.
Absalom AR, Mani V, De Smet T, Struys MMRF. Pharmacokinetic models for propofol—defining and illuminating the devil in the detail. Br J Anaesth. 2009;103:26–37.CrossRef
Metadata
Title
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
Authors
David W. Hewson
Frank Worcester
James Sprinks
Murray D. Smith
Heather Buchanan
Philip Breedon
Jonathan G. Hardman
Nigel M. Bedforth
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3228-4

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