Deep Sedation Events During Diagnostic Upper Gastrointestinal Endoscopy: A Randomized Study of the Regimens Propofol-Fentanyl and Midazolam-Fentanyl

Abstract

Gastrointestinal Endoscopy Unit - Gastroenterology Department, University of Sao Paulo Medical School, Sao Paulo, Brazil Background and Study Aims: For upper gastrointestinal endoscopy (UGIE), the use of sedation is nearly universal. The objective of this study was to compare two drug combinations in terms of the frequency of deep sedation events during UGIE. Patients and Methods: We evaluated 200 patients referred for UGIE. Patients were randomized to receive propofol-fentanyl or midazolam-fentanyl (n = 100/group). We assessed the level of sedation with the Observer’s Assessment of Alertness/Sedation (OAA/S) and the bispectral index (BIS). We evaluated patient and physician satisfaction, as well as recovery time and complication rates. Results: The times to induction sedation, recovery, and discharge were shorter in the propofol-fentanyl group than in the midazolam-fentanyl group. According to the OAA/S, deep sedation events occurred in 25% of the propofol-fentanyl group patients and 11% of the midazolam-fentanyl group patients (p = 0.014), compared with 19% and 7%, respectively, for the BIS (p = 0.039). There was good concordance between the OAA/S and the BIS for both groups (k = 0.71 and k = 0.63, respectively). Oxygen supplementation was required in 42% of the propofol-fentanyl group patients and in 26% of the midazolam-fentanyl group patients (p = 0.025). The mean time to recovery was 28.82 and 44.13 min in the propofol-fentanyl and midazolam-fentanyl groups, respectively (p < 0.001). There were no severe complications in either group. Although patients were equally satisfied with both drug combinations, physicians were more satisfied with the propofol-fentanyl combination. Conclusions: Despite the greater risk of deep sedation, propofol is preferable to midazolam.