Background: The purposes of this study are: (1) to prospectively evaluate clinically relevant outcomes including sedation-related complications for endoscopic ultrasound (EUS) procedures performed with the use of propofol deep sedation administered by monitored anesthesia care (MAC), and (2) to compare these results with a historical case-control cohort of EUS procedures performed using moderate sedation provided by the gastrointestinal (GI) endoscopist.
Materials and methods: Patients referred for EUS between January 1, 2001 and December 31, 2002 were enrolled. Complication rates for EUS using MAC sedation were observed and also compared with a historical case-control cohort of EUS patients who received meperidine/midazolam for moderate sedation, administered by the GI endoscopist. Logistic regression analysis was used to isolate possible predictors of complications.
Results: A total of 1,000 patients underwent EUS with propofol sedation during the period from January 1, 2001 through December 31, 2002 (mean age 64 years, 53% female). The distribution of EUS indications based on the primary area of interest was: 170 gastroduodenal, 92 anorectal, 508 pancreaticohepatobiliary, 183 esophageal, and 47 mediastinal. The primary endpoint of the study was development of sedation-related complications occurring during a performed procedure. A total of six patients experienced complications: duodenal perforation (one), hypotension (one), aspiration pneumonia (one), and apnea requiring endotracheal intubation (three). The complication rate with propofol was 0.60%, compared with 1% for the historical case-control (meperidine/midazolam moderate sedation) group.
Conclusions: There does not appear to be a significant difference between complication rates for propofol deep sedation with MAC and meperidine/midazolam administered for moderate sedation.