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A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol.

ABSTRACT: Background:Procedural sedation is a core skill of the emergency physician. Bolus administration of propofol is widely utilised in UK emergency departments to provide procedural sedation. Bolus administration of propofol, titrated to an endpoint of sedation, has a rapid effect but can easily result in apnoea and loss of airway patency. The use of a target-controlled infusion of propofol allows for controlled titration to an effect site concentration and may reduce the rate of adverse incidents. Target-controlled infusion of propofol is not currently used in emergency departments.The primary aim of this feasibility study is to ensure that propofol target-controlled infusion (TCI) is acceptable to the patient and that recruitment rates are adequate to power a randomised controlled trial comparing propofol target-controlled infusion versus bolus administration. Methods:This study will recruit in four emergency departments in Scotland, UK. Patients aged 18-65?years with anterior shoulder dislocation, weighing ??50?kg and fasted ??90?min, will be screened. Recruited patients will undergo emergency reduction of a dislocated shoulder facilitated by procedural sedation utilising TCI of propofol.The widespread adoption of TCI propofol by emergency departments will require evidence that it is safe, potentially effective, patient centred and a timely method of providing procedural sedation. The primary endpoint will be acceptability measured by patient satisfaction. The secondary endpoints will include incidence and severity of adverse events, number of shoulder reduction attempts, nursing opinion of patient experience, patient's reported pain score and time from commencement of TCI propofol sedation to desired sedation level.The study will be open for recruitment from April 2017 to December 2018. Discussion:If the study demonstrates patient acceptability with adequate recruitment, we will be in a position to determine the feasibility of progression to a randomised controlled clinical trial of TCI compared to bolus administration of propofol. Trial registration:ClinicalTrials.gov Identifier: NCT03442803. Registered retrospectively on 22 February 2018.

SUBMITTER: Burton FM

PROVIDER: S-EPMC6378735 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol.

Burton Fiona M FM Lowe David J DJ Millar Jonathan J Corfield Alasdair R AR Sim Malcolm A B MAB

Pilot and feasibility studies 20190218

<h4>Background</h4>Procedural sedation is a core skill of the emergency physician. Bolus administration of propofol is widely utilised in UK emergency departments to provide procedural sedation. Bolus administration of propofol, titrated to an endpoint of sedation, has a rapid effect but can easily result in apnoea and loss of airway patency. The use of a target-controlled infusion of propofol allows for controlled titration to an effect site concentration and may reduce the rate of adverse inci ...[more]

PMID: 30820338

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Project description:BACKGROUND:Propofol sedation is effective for gastrointestinal endoscopic procedures, but its narrow therapeutic window highlights the importance of identifying an optimal administration technique regarding effectiveness and safety. This study aimed to determine the incidence of significant adverse events in adult patients scheduled for gastrointestinal endoscopy under anaesthetist-performed sedation using propofol target-controlled infusion and determine the existence of associations between these events and potentially related variables. METHODS:This single-centre, retrospective cohort study took place in a tertiary referral university hospital. Medical records of 823 patients (age?>?18?years, American Society of Anesthesiologists physical status classification scores I-III) who had undergone elective gastrointestinal endoscopy under propofol target-controlled infusion sedation during September 2018 were reviewed. Outcomes included hypoxia, hypotension, and bradycardia events, requirement of vasoactive drugs, unplanned tracheal intubation or supraglottic device insertion, and need for advanced cardiac life support. RESULTS:The most frequently encountered adverse event was oxygen desaturation <?95% with an incidence of 22.35%. Vasoactive drug administration, hypotension, and oxygen desaturation <?90% followed, with incidences of 19.2, 12.64, and 9.92%, respectively. Only 0.5% of patients required advanced airway management. Multivariate analysis revealed an association between hypotension events, colonoscopic procedures, and propofol doses (odds ratio: 3.08, 95% confidence interval: 1.43 to 6.61; P?=?0.004 and odds ratio: 1.14, 95% confidence interval: 1.00 to 1.29; P?=?0.046). A strong dose-effect relationship was found between hypoxia and obesity; patients with body mass index ?40 were nine times (odds ratio: 10.22, 95% confidence interval: 2.83 to 36.99) more likely to experience oxygen desaturation <?90% events. CONCLUSIONS:Propofol sedation using target-controlled infusion appears to be a safe and effective anaesthetic technique for gastrointestinal endoscopic procedures with acceptable rates of adverse events and could be more widely adopted in clinical practice.

Project description:Target-controlled infusion (TCI) provides precise pharmacokinetic control of propofol concentration in the effect-site (Ce), eg. brain. This pilot study aims to evaluate the feasibility and optimal TCI regimen for flexible bronchoscopy (FB) sedation.After alfentanil bolus, initial induction Ce of propofol was targeted at 2 ?g/ml. Patients were randomized into three titration groups (i.e., by 0.5, 0.2 and 0.1 ?g/ml, respectively) to maintain stable sedation levels and vital signs. Adverse events, frequency of adjustments, drug doses, and induction and recovery times were recorded.The study was closed early due to significantly severe hypoxemia events (oxyhemoglobin saturation <70%) in the group titrated at 0.5 ?g/ml. Forty-nine, 49 and 46 patients were enrolled into the 3 respective groups before study closure. The proportion of patients with hypoxemia events differed significantly between groups (67.3 vs. 46.9 vs. 41.3%, p?=?0.027). Hypotension events, induction and recovery time and propofol doses were not different. The Ce of induction differed significantly between groups (2.4±0.5 vs. 2.1±0.4 vs. 2.1±0.3 ?g/ml, p?=?0.005) and the Ce of procedures was higher at 0.5 ?g/ml titration (2.4±0.5 vs. 2.1±0.4 vs. 2.2±0.3 ?g/ml, p?=?0.006). The adjustment frequency tended to be higher for titration at 0.1 ?g/ml but was not statistically significant (2 (0?6) vs. 3 (0?6) vs. 3 (0?11)). Subgroup analysis revealed 14% of all patients required no further adjustment during the whole sedation. Comparing patients requiring at least one adjustment with those who did not, they were observed to have a shorter induction time (87.6±34.9 vs. 226.9±147.9 sec, p<0.001), a smaller induction dose and Ce (32.5±4.1 vs. 56.8±22.7 mg, p<0.001; 1.76±0.17 vs. 2.28 ±0.41, p<0.001, respectively), and less hypoxemia and hypotension (15.8 vs.56.9%, p?=?0.001; 0 vs. 24.1%, p?=?0.008, respectively).Titration at 0.5 ?g/ml is risky for FB sedation. A subgroup of patients required no more TCI adjustment with fewer complications. Further studies are warranted to determine the optimal regimen of TCI for FB sedation.ClinicalTrials.gov NCT01101477.

Project description:OBJECTIVES:Outcomes associated with a sedative regimen comprised ketamine + propofol for pediatric procedural sedation outside of both the pediatric emergency department and operating room are underreported. We used the Pediatric Sedation Research Consortium database to describe a multicenter experience with ketamine + propofol by pediatric sedation providers. DESIGN:Prospective observational study of children receiving IV ketamine + propofol for procedural sedation outside of the operating room and emergency department using data abstracted from the Pediatric Sedation Research Consortium during 2007-2015. SETTING:Procedural sedation services from academic, community, free-standing children's hospitals, and pediatric wards within general hospitals. PATIENTS:Children from birth to less than or equal to 21 years old. INTERVENTIONS:None. MEASUREMENTS AND MAIN RESULTS:A total of 7,313 pediatric procedural sedations were performed using IV ketamine + propofol as the primary sedative regimen. Median age was 84 months (range, < 1 mo to ? 21 yr; interquartile range, 36-144); 80.6% were American Society of Anesthesiologists-Physical Status less than III. The majority of sedation was performed in dedicated sedation or radiology units (76.1%). Procedures were successfully completed in 99.8% of patients. Anticholinergics (glycopyrrolate and atropine) or benzodiazepines (midazolam and lorazepam) were used in 14.2% and 41.3%, respectively. The overall adverse event and serious adverse event rates were 9.79% (95% CI, 9.12-10.49%) and 3.47% (95% CI, 3.07-3.92%), respectively. No deaths occurred. Risk factors associated with an increase in odds of adverse event included ASA status greater than or equal to III, dental suite, cardiac catheterization laboratory or radiology/sedation suite location, a primary diagnosis of having a gastrointestinal illness, and the coadministration of an anticholinergic. CONCLUSIONS:Using Pediatric Sedation Research Consortium data, we describe the diverse use of IV ketamine + propofol for procedural sedation in the largest reported cohort of children to date. Data from this study may be used to design sufficiently powered prospective randomized, double-blind studies comparing outcomes of sedation between commonly administered sedative and analgesic medication regimens.

Project description:BackgroundAccidental Accidental awareness during general anesthesia (AAGA) occurs in 1-2% of high-risk practice patients and is a cause of severe psychological trauma, termed post-traumatic stress disorder (PTSD). However, no monitoring techniques can accurately predict or detect AAGA. Since the first reflex for a patient during AAGA is to move, a passive brain-computer interface (BCI) based on the detection of an intention of movement would be conceivable to alert the anesthetist. However, the way in which propofol (i.e., an anesthetic commonly used for the general anesthesia induction) affects motor brain activity within the electroencephalographic (EEG) signal has been poorly investigated and is not clearly understood. For this reason, a detailed study of the motor activity behavior with a step-wise increasing dose of propofol is required and would provide a proof of concept for such an innovative BCI. The main goal of this study is to highlight the occurrence of movement attempt patterns, mainly changes in oscillations called event-related desynchronization (ERD) and event-related synchronization (ERS), in the EEG signal over the motor cortex, in healthy subjects, without and under propofol sedation, during four different motor tasks.MethodsMOTANA is an interventional, prospective, exploratory, physiological, monocentric, and randomized study conducted in healthy volunteers under light anesthesia, involving EEG measurements before and after target-controlled infusion of propofol at three different effect-site concentrations (0 μg.ml -1, 0.5 μg.ml -1, and 1.0 μg.ml -1). In this exploratory study, 30 healthy volunteers will perform 50 trials for the four motor tasks (real movement, motor imagery, motor imagery with median nerve stimulation, and median nerve stimulation alone) in a randomized sequence. In each conditions and for each trial, we will observe changes in terms of ERD and ERS according to the three propofol concentrations. Pre- and post-injection comparisons of propofol will be performed by paired series tests.DiscussionMOTANA is an exploratory study aimed at designing an innovative BCI based on EEG-motor brain activity that would detect an attempt to move by a patient under anesthesia. This would be of interest in the prevention of AAGA.Trial registrationAgence Nationale de Sécurité du Médicament (EUDRACT 2017-004198-1), NCT03362775. Registered on 29 August 2018. https://clinicaltrials.gov/ct2/show/NCT03362775?term=03362775&rank=1.

Project description:BackgroundFearful and anxious patients who find dental treatment intolerable without sedative and analgesic support may benefit from moderate sedation. Target controlled infusion (TCI) pumps are superior to bolus injection in maintaining low plasma and effect-site concentration variability, resulting in stable, steady-state drug concentrations. We evaluated the safety and efficacy of moderate sedation with remifentanil and propofol using TCI pumps in non-hospital dental settings.MethodsA prospective chart review was conducted on 101 patients sedated with propofol and remifentanil using TCI pumps. The charts were completed at two oral surgeons and one general dentist's office over 6 months. Hypoxia, hypotension, bradycardia, and over-sedation were considered adverse events and were collected using Tracking and Reporting Outcomes of Procedural Sedation (TROOPS). Furthermore, patient recovery time, sedation length, drug dose, and patient satisfaction questionnaires were used to measure sedation effectiveness.ResultsOf the 101 reviewed sedation charts, 54 were of men, and 47 were of women. The mean age of the patients was 40.5 ±18.7 years, and their mean BMI was 25.6 ± 4.4. The patients did not experience hypoxia, bradycardia, and hypotension during the 4694 min of sedation. The average minimum Mean Arterial Pressure (MAP) and heartbeats were 75.1 mmHg and 60.4 bpm, respectively. 98% of patients agreed that the sedation technique met their needs in reducing their anxiety, and 99% agreed that they were satisfied with the sedation 24 hours later. The average sedation time was 46.9 ± 55.6 min, and the average recovery time was 12.4 ± 4.4 min. Remifentanil and propofol had mean initial effect-site concentration doses of 0.96 µ/ml and 1.0 ng/ml respectively. The overall total amount of drug administered was significantly higher in longer sedation procedures compared to shorter ones, while the infusion rate decreased as the procedural stimulus decreased.ConclusionAccording to the results of this study, no patients experienced adverse events during sedation, and all patients were kept at a moderate sedation level for a wide range of sedation times and differing procedures. The results showed that TCI pumps are safe and effective for administering propofol and remifentanil for moderate sedation in dentistry.

Project description:ObjectivesDeep sedation in the emergency department (ED) is common, increases deep sedation in the ICU, and is negatively associated with outcome. Limiting ED deep sedation may, therefore, be a high-yield intervention to improve outcome. However, the feasibility of conducting an adequately powered ED-based clinical sedation trial is unknown. Our objectives were to assess trial feasibility in terms of: 1) recruitment, 2) protocol implementation and practice change, and 3) safety. Patient-centered clinical outcomes were assessed to better plan for a future large-scale clinical trial.DesignPragmatic, multicenter ( n = 3), prospective before-after pilot and feasibility trial.SettingThe ED and ICUs at three medical centers.PatientsConsecutive, adult mechanically ventilation ED patients.InterventionsAn educational initiative aimed at reliable ED sedation depth documentation and reducing the proportion of deeply sedated patients (primary outcome).Measurements and main resultsSedation-related data in the ED and the first 48 ICU hours were recorded. Deep sedation was defined as a Richmond Agitation-Sedation Scale of -3 to -5 or a Sedation-Agitation Scale of 1-3. One thousand three hundred fifty-six patients were screened; 415 comprised the final population. Lighter ED sedation was achieved in the intervention group, and the proportion of deeply sedated patients was reduced from 60.2% to 38.8% ( p < 0.01). There were no concerning trends in adverse events (i.e., inadvertent extubation, device removal, and awareness with paralysis). Mortality was 10.0% in the intervention group and 20.4% in the preintervention group ( p < 0.01). Compared with preintervention, the intervention group experienced more ventilator-free days [22.0 (9.0) vs 19.9 (10.6)] and ICU-free days [20.8 (8.7) vs 18.1 (10.4)], p < 0.05 for both.ConclusionsThis pilot trial confirmed the feasibility of targeting the ED in order to improve sedation practices and reduce deep sedation. These findings justify an appropriately powered clinical trial regarding ED-based sedation to improve clinical outcomes.

Dataset Information

A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol.

Publications

A study protocol for a feasibility study: Propofol Target-Controlled Infusion in Emergency Department Sedation (ProTEDS)-a multi-centre feasibility study protocol.

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