Abstract
Each year, many operations in the UK are performed with the patient awake, without the use of general anaesthesia. These include joint replacement procedures, and in order to reduce patient anxiety, the supervising anaesthetist delivers the sedative propofol intravenously using a target-controlled infusion (TCI) device. However, it is clinically challenging to judge the required effect-site concentration of sedative for an individual patient, resulting in patient care issues related to over or under-sedation. To improve the process, patient-maintained propofol sedation (PMPS), where the patient can request an increase in concentration through a hand-held button, has been considered as an alternative. However, due to the proprietary nature of modern TCI pumps, the majority of PMPS research has been conducted using prototypes in research studies. In this work, a PMPS system is presented that effectively converts a standard infusion pump into a TCI device using a laptop with TCI software. Functionally, the system delivers sedation analogous to a modern TCI pump, with the differences in propofol consumption and dosage within the tolerance of clinically approved devices. Therefore, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the system as a safe alternative to anaesthetist-controlled TCI procedures. It represents a step forward in the consideration of PMPS as a sedation method as viable alternative, allowing further assessment in clinical trials.
Highlights
A considerable number of operations performed annually in the UK are conducted in the presence of an anaesthetist, but without using general anaesthesia [1]
Some of the risks associated with general anaesthesia [3]
To date there has been only a small number of randomised controlled trials of patient-maintained propofol sedation (PMPS) in a clinical setting [20,21,22], of which none have used modern propofol target-controlled infusion (TCI) pumps with the pharmacokinetic algorithm ‘built in’ as an option (i.e. Schnider effect-site modelling [10]) in comparing PMPS against the anaesthetist-controlled standard
Summary
A considerable number of operations (over 800,000) performed annually in the UK are conducted in the presence of an anaesthetist, but without using general anaesthesia [1]. J Med Syst (2019) 43: 247 more rapid patient wake-up, less post-procedural confusion and delirium, and the ability to convert to general anaesthesia if required [12] In such a system, a target-controlled infusion device delivers an infusion rate of propofol that varies over time to achieve a specified plasma or effect-site (i.e. brain) drug concentration (Fig. 1). To date there has been only a small number of randomised controlled trials of PMPS in a clinical setting [20,21,22], of which none have used modern propofol TCI pumps with the pharmacokinetic algorithm ‘built in’ as an option (i.e. Schnider effect-site modelling [10]) in comparing PMPS against the anaesthetist-controlled standard This is, in part, because modern TCI infusions devices The performance of the proposed PMPS system is compared to a modern TCI integrated infusion pump, in terms of propofol dosage and total consumption for different patient demographics and target effect-site levels
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