This is a noninferiority study designed to examine whether conscious sedation with midazolam
alone results in efficacy and safety that is not inferior to the combination of midazolam and
fentanyl. English-speaking patients ≥18 years old and ≤75 years old presenting for GI
endoscopy planned with conscious sedation using midazolam and fentanyl, will be randomized
1:1 to single agent sedation with midazolam or combination sedation with midazolam and
fentanyl. Participants will be blinded to the choice of sedation. Sedation quality and
adverse events will be measured with a validated patient-centered measure of procedural
sedation quality, the PROcedural Sedation Assessment Survey (PROSAS) [Leffler, et al.
Gastrointest Endosc. 2015;81(1):194-203]. Endoscopic quality measures in the 2 study groups
will be collected by retrospective chart review, as an additional metric to ensure the
quality of the procedure is not compromised by the choice of sedation.