BACKGROUND Endoscopic retrograde cholangiopancreatography (ERCP) is one of the most complex gastrointestinal endoscopic procedures. Currently, it is still unclear which sedation regimen best facilitates an ERCP. The N-methyl-d-aspartate receptor antagonist esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less cardiorespiratory depression than other sedatives. It could therefore be an ideal adjunct to propofol for deep sedation. OBJECTIVE To assess the effectiveness of esketamine versus alfentanil as an adjunct to propofol target-controlled infusion (TCI) for deep sedation during ambulant ERCP. DESIGN A randomised controlled multicentre study. SETTING Endoscopic intervention suite at an academic and general hospital in the Netherlands. PARTICIPANTS Adult, American Society of Anesthesiologists Physical Status I to III patients scheduled to undergo ERCP. INTERVENTION Consecutive patients were randomly assigned to receive sedation for an ERCP with propofol TCI and alfentanil (group A) or with propofol TCI and esketamine (group E). MAIN OUTCOME MEASURES The primary outcome was effectiveness of the sedation regimen expressed as the total dose of propofol – as a surrogate parameter – necessary to perform ERCP in a satisfactory manner for endoscopist and patients. Secondary outcomes were recovery time, patients’ and endoscopists’ satisfaction with sedation, side effects (e.g. psychotomimetic effects, nausea and vomiting) and the number of respiratory and cardiovascular adverse events. RESULTS Data from 162 patients were analysed. The total dose of propofol required was significantly lower in group E (n=83) (8.3 mg kg−1 h−1) than in group A (n=79) (10.5 mg kg−1 h−1) (P < 0.001). There were no significant differences in recovery time, patients’ and endoscopists’ satisfaction, side effects, psychotomimetic effects and the number of sedation-related adverse events. CONCLUSION Low-dose esketamine reduces the total amount of propofol necessary for sedation during ERCP in American Society of Anesthesiologists I and II patients without affecting recovery time, satisfaction of patients and endoscopists, side effects and respiratory or cardiovascular adverse events, when compared with alfentanil. TRIAL REGISTRATION The Netherlands Trial Register (NTR5486).
We describe the impact of a targeted performance improvement programme and the associated performance improvement interventions, on mortality rates, error rates and process of care for haemodynamically unstable patients with pelvic fractures. Clinical care and performance improvement data for 185 adult patients with exsanguinating pelvic trauma presenting to a United Kingdom Major Trauma Centre between January 2007 and January 2011 were analysed with univariate and multivariate regression and compared with National data. In total 62 patients (34%) died from their injuries and opportunities for improved care were identified in one third of deaths. Three major interventions were introduced during the study period in response to the findings. These were a massive haemorrhage protocol, a decision-making algorithm and employment of specialist pelvic orthopaedic surgeons. Interventions which improved performance were associated with an annual reduction in mortality (odds ratio 0.64 (95% confidence interval (CI) 0.44 to 0.93), p = 0.02), a reduction in error rates (p = 0.024) and significant improvements in the targeted processes of care. Exsanguinating patients with pelvic trauma are complex to manage and are associated with high mortality rates; implementation of a targeted performance improvement programme achieved sustained improvements in mortality, error rates and trauma care in this group of severely injured patients.
BackgroundEndoscopic retrograde cholangiopancreatography (ERCP) is a gastrointestinal procedure that requires a relatively motionless patient during the intervention. Deep sedation by intravenous propofol combined with an opioid has recently become the preferred sedation technique. However, when high doses of propofol are used, side effects, namely respiratory depression, may occur. Esketamine has hypnotic, analgesic, and sympathomimetic effects. Our assumption is that a combination of propofol with esketamine reduces the dosage of individual drugs, thereby minimizing sedation side effects while keeping the same satisfaction level of patients and endoscopists.Methods/designThe study will be performed as a randomized controlled multicenter trial. Patients undergoing ERCP, ≥ 18 years old, with American Society of Anesthesiologists (ASA) classification I–III will be randomized after written informed consent to group K (propofol/esketamine) or to group A (propofol/alfentanil). The primary outcome, reflecting effectiveness of sedation, is the total dose of propofol. Secondary outcome parameters are patients’ and endoscopists’ satisfaction with the procedure and the number of sedation-related pulmonary and cardiovascular events. Data on sedation-related events are collected by recording of oxygen saturation (SpO2), respiratory rate (RR), end-tidal CO2 (etCO2), heart rate (HR), arrhythmias (electrocardiogram (ECG)), and non-invasive blood pressure (NIBP) measurements. Satisfaction parameters are collected by means of questionnaires before and after the procedure and on the following day.DiscussionEsketamine is known for its effective anesthetic and analgesic effects maintaining spontaneous breathing and airway reflexes. Due to an increase in sympathetic tone, hypotension and cardiac depression is less common. Unfortunately esketamine is also known for its psychotomimetic effects. We aim to demonstrate that the combination of esketamine with propofol for sedation in patients subjected to ERCP interventions is nevertheless superior to a combination of propofol with an opioid.Trial registrationNederland’s Trial Register, NTR5486. Registered on 17 September 2015.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2197-8) contains supplementary material, which is available to authorized users.
IMPORTANCE Failure to rescue causes significant morbidity and mortality in the surgical population. Human error is often the underlying cause of failure to rescue. Human error can be reduced by the use of cognitive aids.OBJECTIVES To test the effectiveness of cognitive aids on adherence to best practice in the management of deteriorating postoperative surgical ward patients. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial in a simulation setting. Surgical teams consisted of 1 surgeon and 2 nurses from a surgical ward from 4 different hospitals in Amsterdam, the Netherlands. Data were analyzed between February 2, 2017, and December 18, 2018.INTERVENTIONS The teams were randomized to manage 3 simulated deteriorating patient scenarios with or without the use of cognitive aids. MAIN OUTCOMES AND MEASURESThe primary outcome of the study was failure to adhere to best practice, expressed as the percentage of omitted critical management steps. The secondary outcome of the study was the perceived usability of the cognitive aids. RESULTSOf the total participants, 93 were women and 51 were men. Twenty-five surgical teams performed 75 patient scenarios with cognitive aids, and 25 teams performed 75 patient scenarios without cognitive aids. Using the cognitive aids resulted in a reduction of omitted critical management steps from 33% to 10%, which is a 70% (P < .001) reduction. This effect remained significant (odds ratio, 0.63; 95% CI, −0.228 to −0.061; P = .001) in a multivariate analysis. Overall usability (scale of 0-10) of the cognitive aids was scored at a median of 8.7 (interquartile range, 8-9). CONCLUSIONS AND RELEVANCEFailure to comply with best practice management of postoperative complications is associated with worse outcomes. In this simulation study, adherence to best practice in the management of postoperative complications improves significantly by the use of cognitive aids. Cognitive aids for deteriorating surgical patients therefore have the potential to reduce failure to rescue and improve patient outcome.
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