Patient-maintained Propofol Sedation Research Articles

A Prototype Patient-Maintained Propofol Sedation System Using Target Controlled Infusion for Primary Lower-Limb Arthroplasty

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.

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

BackgroundThe 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.MethodsThe 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.DiscussionThis 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 registrationInternational Standard Randomised Controlled Trial Number Registry, ISRCTN29129799. Prospectively registered on 12 June 2018.

Reaction time monitored patient maintained propofol sedation: a volunteer safety study

Reaction time monitored patient maintained propofol sedation: a volunteer safety study

Evaluation of a new effect‐site controlled, patient‐maintained sedation system in dental patients*

We have designed a new effect-site controlled, patient-maintained sedation system for delivering propofol. In the previous systems we developed, the patients retained the use of the handset throughout the procedure and were able to increase the level of sedation. However, it was found that this could potentially lead to oversedation. In the present system, the patients were able to increase their level of sedation until a level was reached that was judged by the patients as being adequate to allow them to tolerate the injection of dental local anaesthetic. The handset was then taken from the patients and the effect site concentration of propofol was maintained at that level for the remainder of the procedure. To assess its safety and efficacy, the system was used to sedate 40 patients presenting for dental procedures under sedation. The system was used successfully and treatment was completed in 39 patients. The system was found to be safe. Both surgeon and patient approval scores were high. Although this study demonstrates the efficacy of effect-site controlled, patient-maintained propofol sedation in this group of patients, further work is required to confirm its safety.

Effect‐site controlled patient maintained propofol sedation: a volunteer safety study*

Effect-site concentration is a mathematical term related to the clinical effect of a drug. We have designed a patient-maintained sedation system for delivering propofol to the predicted effect-site concentration rather than plasma concentration. To assess its efficacy and safety, 20 healthy volunteers deliberately attempted to over-sedate themselves using the system. The new effect-site concentration driven system delivered sedation successfully, and more rapidly than its predecessor. Fifteen volunteers ended the study when the system automatically reduced the effect-site concentration after 6 min of no button presses despite verbal contact and maintenance of arterial oxygen saturation (at effect-site concentration 1.8-3.8 microg x ml(-1)). Four out of 20 volunteers ended with minor arterial desaturation (lowest 88% at effect-site concentration 2.6-3.4 microg x ml(-1)). One volunteer ended after loss of verbal contact at effect-site concentration 3.4 microg x ml(-1). Further modification of the system's design is necessary before it can be recommended for routine practice.

Patient maintained sedation for colonoscopy using a target controlled infusion of propofol*

In this study, we evaluated safety and recovery using a patient maintained, target controlled infusion of propofol for sedation in 20 patients undergoing colonoscopy. Using a handset with a two-minute lockout interval, patients could make 0.2 micro g.ml(-1) increments to an initial target plasma concentration of 1 micro g.ml(-1) up to a maximum 4.5 micro g.ml(-1). Four patients became oversedated but required no airway or circulatory interventions. Subjects had a significant reduction in mean (SD) heart rate: 78.7 (15) vs. 69.8 (13.5) (p < 0.001) and in systolic blood pressure 121.1 (13.2) mmHg vs. 96.5 (8.6) mmHg (p < 0.001). Choice reaction time testing 15 min after colonoscopy showed a significant median (IQR [range]) rise of 162 (- 16, 383.3 [-199-859]) ms (p < 0.05). Six patients had faster reaction times postcolonoscopy. All patients denied unpleasant recall and were satisfied with the system. Although oversedation was a problem in this model, we conclude that patient maintained propofol sedation could be possible for colonoscopy.

Patient-maintained propofol sedation as premedication in day-case surgery: assessment of a target-controlled system

We have assessed the efficacy and safety of a system which allowed 20 patients undergoing day-case anaesthesia to operate a target-controlled infusion of propofol to provide anxiolytic premedication. A target-controlled infusion of propofol was started with a target blood concentration of 1 microgram ml-1, and the patient was allowed to increase the target by 0.2 microgram ml-1 by operating a control button. There was a lockout time of 2 min and a maximum target concentration of 3 micrograms ml-1. There were significant reductions in anxiety scores from presedation baseline values and those measured at 15 min after the start of sedation. Values remained low until induction of anaesthesia. Median blood target concentration of propofol varied from 1.0 to 1.2 micrograms ml-1 and mean propofol consumption was 50.3 (SD 17.6) micrograms kg-1 min-1. No patient became oversedated and all remained cardiovascularly stable. Two individuals required low-dose supplementary oxygen for mild arterial oxygen desaturation but there were no instances of airway obstruction. Patient satisfaction with the system was high.