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Randomized Clinical Trial of Etomidate Versus Propofol for Procedural Sedation in the Emergency Department

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Randomized Clinical Trial of Etomidate Versus Propofol for Procedural Sedation in the Emergency Department SEDATION AND PAIN MANAGEMENT/ORIGINAL RESEARCH Randomized Clinical Trial of Etomidate Versus Propofol for Procedural Sedation in the Emergency Department James R. Miner, MD From the Department of Emergency Medicine, Hennepin County Medical Center, Minneapolis, MN. Mark Danahy, MD Abby Moch, BS Michelle Biros, MS, MD Study objective: We compare the efficacy, adverse events, and recovery duration of etomidate and propofol for use in procedural sedation in the emergency department (ED). Methods: This was a randomized nonblinded prospective trial of adult patients undergoing procedural sedation for painful procedures in the ED. Patients received either propofol or etomidate. Doses, vital signs, nasal end-tidal CO2 (ETCO2), pulse oximetry, and bispectral electroencephalogram analysis scores were recorded. Subclinical respiratory depression was defined as a change in ETCO2 greater than 10 mm Hg, an oxygen saturation of less than 92% at any time, or an absent ETCO2 waveform at any time. Clinical events related to respiratory depression, including an increase in supplemental oxygen, the use of a bag-valve-mask apparatus, airway repositioning, or stimulation to induce breathing, were noted during the procedure. After the procedure, patients completed visual analog scales about perceived pain during the procedure and recall of the procedure. Results: Two hundred twenty patients were enrolled; 214 underwent sedation and were analyzed. One hundred five patients received etomidate and 109 received propofol. No clinically significant complications were noted. Subclinical respiratory depression was observed in 36 of 105 (34.3%) patients in the etomidate group and 46 of 109 (42.2%) in the propofol group (difference –7.9%; 95% confidence interval [CI] –20.9% to 5.1%). Myoclonus was noted in 21 of 105 (20.0%) patients in the etomidate group and 2 of 109 (1.8%) in the propofol group (difference 18.2%; 95% CI 10.1% to 26.2%). The mean difference between baseline systolic blood pressure and the nadir was 3.8% (95% CI 2.3% to 5.3%) for etomidate and 7.9% (95% CI 6.1% to 9.7%) for propofol. Clinical events related to respiratory depression included an increase in supplemental oxygen in 6.7% of etomidate patients and 5.5% of propofol patients (difference 1.2%; 95% CI –5.2% to 7.6%), the use of bag-valve-mask apparatus in 3.8% of patients in the etomidate groups and 4.6% in the propofol group (difference –0.8%; 95% CI –6.1% to 4.6%), airway repositioning in 13.3% of etomidate patients and 11.0% of propofol patients (effect size 2.3%; 95% CI –6.4% to 11.1%), and stimulation to induce breathing in 11.4% of etomidate patients and 11.9% of propofol patients (difference –0.5%; 95% CI –9.1% to 8.1%). The procedures were successful in 93 of 105 (88.6%) for etomidate and 106 of 109 (97.2%) for propofol (difference –7.4%; 95% CI –14.3% to –1.1%). Conclusion: Etomidate and propofol appear equally safe for ED procedural sedation; however, etomidate had a lower rate of procedural success and induced myoclonus in 20% of patients. [Ann Emerg Med. 2007;49:15-22.] 0196-0644/$-see front matter Copyright © 2007 by the American College of Emergency Physicians. doi:10.1016/j.annemergmed.2006.06.042 SEE EDITORIAL, P. 31. drainage, often require moderate or deep procedural sedation for successful performance of the procedure. This sedation is INTRODUCTION achieved with the use of a sedative agent administered at a dose Background that allows patients to maintain airway reflexes and have some Patients undergoing painful procedures in the emergency response to verbal stimuli (moderate sedation) or to pain (deep department (ED), such as orthopedic manipulations or abscess sedation). The ideal sedative agent for this purpose would Volume , . : January Annals of Emergency Medicine 15 Etomidate Versus Propofol for Procedural Sedation Miner et al the rate of subclinical respiratory depression, the rate of clinical Editor’s Capsule Summary signs of respiratory depression, the time required for patients to What is already known on this topic return to baseline mental status, the success of the procedure, Etomidate and propofol are the most popular ultrashort- and patient-derived outcome factors of perceived pain, recall of acting sedatives for emergency department (ED) deep the procedure, and satisfaction with the care they received. sedation. What question this study addressed MATERIALS AND METHODS Study Design Are the 2 sedatives similar in terms of efficacy, adverse This was a prospective, randomized, nonblinded, clinical events, and recovery duration? trial of propofol versus etomidate for ED procedural sedation of What this study adds to our knowledge patients undergoing painful procedures between June 1, 2004, The 2 sedatives were similar with respect to airway and September 1, 2005. The institutional review board of adverse events and recovery duration; however, etomidate Hennepin County Medical Center approved the study. Patients produced myoclonus in 20% of patients. Success rate provided prospective informed consent before enrollment. with propofol (97%) was higher than with etomidate (90%), which could be due to the drug’s performance Setting but also could be due to differences in case mix between This study was performed at an urban county medical center the groups. with approximately 97,000 ED patient visits per year. In our ED, procedural sedation is performed at the discretion of the How this might change clinical practice treating emergency physician. It is standard practice in our ED This study supports both sedatives as highly satisfactory to treat patients with fractures or dislocations with intravenous for ED deep sedation. This study provides tentative morphine (0.1 mg/kg intravenously followed by 0.05 mg/kg evidence that propofol is superior. intravenously every 10 minutes as needed/tolerated) for pain control as soon as possible in their treatment. provide adequate sedation to perform the procedure successfully, with a minimum of cardiorespiratory adverse Selection of Participants Ͼ effects, and have a short duration of action. Etomidate and All adult (age 18 years) ED patients who were to receive propofol are 2 ultrashort-acting sedative agents thought to procedural sedation using either propofol or etomidate were provide these characteristics.1-17 Despite their common use in eligible for study enrollment. Patients were excluded if they procedural sedation, the performance and safety of these 2 were unable to give consent, had an American Society of 19 agents have not been compared in a randomized controlled Anesthesiologists Physical Assessment Score greater than 2, fashion.18 had a known hypersensitivity to either medication, were Propofol has an onset of action of approximately 45 seconds pregnant, or had clinical evidence of intoxication before the and begins to redistribute from the blood to fat and muscle in 3 start of the procedure. to 5 minutes, with a rapidly resolving clinical effect. Propofol provides reliable amnesia and rapid recovery when used for Interventions procedural sedation.11 Etomidate has an onset of action of Patients began receiving cardiac, blood pressure, pulse approximately 1 minute and duration of action of 5 to 15 oximeter, and nasal sample end-tidal CO2 (ETCO2) monitors minutes. It is considered to have the least homodynamic effect according to standard guidelines for procedural sedation in our of any of the agents available for procedural sedation. A number ED. The ETCO2 monitor (Capnocheck Plus, Smiths BCI, of studies have found that etomidate provides effective, reliable London, England) displays a continuous numerical ETCO2 value sedation with minimal adverse effects.2,5,10,15,17 and waveform. Additionally, patients were also monitored with a bispectral EEG for level of awareness. Baseline values were Importance recorded. Patients were then randomized to receive either Both of these agents are frequently used for procedural propofol, 1 mg/kg bolus followed by 0.5 mg/kg every 3 minutes sedation in the ED, but it is not yet known whether one of as needed for sedation, or etomidate, 0.1 mg/kg followed by these agents is more effective or safe than the other. 0.05 mg/kg every 3 to 5 minutes, as needed. Randomization Determining differences in the effectiveness and safety of these was achieved by selecting a sequentially numbered sealed agents will allow the development of more specific guidelines envelope containing the group assignment, which had been about their use. determined using computer-generated random numbers by the investigators. Neither patients nor physicians were blinded to Goals of This Investigation the agent being administered. The use of supplemental oxygen This study prospectively compared procedural sedation with during procedural sedation was at the discretion of the treating etomidate or propofol in terms of the level of sedation achieved, physician. 16 Annals of Emergency Medicine Volume , . : January Miner et al Etomidate Versus Propofol for Procedural Sedation Outcome Measures The Observer’s Assessment of Alertness score was also recorded Subclinical respiratory depression was defined as a change every minute. Any loss of ETCO2 waveform or use of airway from baseline ETCO2 of greater than 10 mm Hg, an oxygen adjuncts, such as bag-valve-mask-assisted respirations or oral saturation of less than 92% at any time during the procedure, or airway placement, was noted. Any clinical events relating to airway obstruction with cessation of gas exchange at any time respiratory depression were recorded as well. Data were collected 12,13,20 (noted by an absent ETCO2 waveform). These are criteria by a designated research assistant during the procedure and then we have used to detect subclinical respiratory depression in entered into an Excel (Microsoft, Redmond, WA) database for previous studies of procedural sedation. It is presumed that further analysis. increases in ETCO2 are indicative of hypercapnia and decreases are due to increased mixing of the breath sample with room air Primary Data Analysis because of airway obstruction or decreasing tidal volume.
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