Safety and Risk Factors for Procedural Sedation in the 21st Century: a Review of Over 2 Million Patients From 2000-2011 John J. Vargo*, Douglas O. Faigel, Paul Niklewski, James Martin, Jeffrey L. Williams, Jennifer L. Holub Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH; Gastroenterology & Hepatology, Mayo Clinic, Scottsdale, AZ; Ethicon Endo-Surgery, Cincinnati, OH; Department of Gastroenterology, Oregon Health and Science University, Portland, OR; Neuroscience, University of Cincinnati, Cincinnati, OH Background: The advent of propofol-mediated sedation and the use of anesthesia professionals (APanesthesiologist or nurse anesthetist) have changed the procedural sedation landscape over the past ten years. The identification of risk factors for serious adverse events during EGD and colonoscopy in this new landscape has not been well studied. Aim: To assess the prevalence and risk factors for serious interventions as related to procedural sedation. Design: Retrospective cohort study. A procedure specific multivariate logistic regression analysis was performed, with covariates including age, gender, ASA classification, sedationist, and procedure indications. Setting: Clinical Outcomes Research Initiative National Endoscopy Database, 2000-2011. Patients: Adults undergoing colonoscopy or EGD procedures in 84 academic, VA and community sites throughout the US. Main Outcome Measurement: The risk of serious intervention based on the use of hemostasis, CPR, hospital/ER admittance, sedation reversal, emergency surgery, stopped procedure, and blood transfusion. Results: 1,372,524 colonoscopy and 805,006 EGD patients were included with 70% seen in the community setting. The presence of an AP increased from 4.3% to 23.5% for colonoscopy and from 4.1% to 23.4% for EGD procedures during this 11 year period. Propofol use increased from 2.3% to 24.5% for colonoscopy and 1.8% to 21.5% for EGD. Fentanyl use increased (colonoscopy 27.1 to 65.5%, EGD 25.1 to 67.2%) and meperidine use decreased (colonoscopy 68.2 to 5.4%, EGD 60.2 to 5.4%). CPR remained stable across the 11 years at 0.005% for colonoscopy and 0.05% for EGD. Use of a reversal agent for colonoscopy decreased from 0.17% to 0.01% and from 0.20% to 0.02% for EGD. 18 deaths were reported for EGD (4 possibly due to sedation, bradycardia/hypoxemia). 8 deaths were reported for colonoscopy (1 possibly due to sedation, hypoxemia). The table shows older age, higher ASA classifications, narcotic administration, trainee involvement, certain non-screening indications, and presence of AP for EGD procedures are associated with increased risk of serious events. Limitations: The main outcome measurement assesses procedural interventions and is not limited to only interventions directly related to sedation. Fields pertaining to sedationist and procedure medications are not required in the CORI software, leading to some missing data. Conclusion: We identified sedation practice changes over this time period and risk factors for adverse outcomes related to procedural sedation. In this analysis of over 2.1 million patients across 11 years, it is clear that sedation during routine colonoscopy and EGD has an excellent safety profile for healthy patients when administered by endoscopists. Utilization of an anesthesia provider did not improve patient safety; in fact the endoscopist was safer for EGD procedures.
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