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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
300
elimination of fentanyl from conscious sedation
Northwestern Memorial Hospital
Chicago, Illinois, United States
Pain Felt During the Procedure
Level of discomfort during the procedure as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "How much discomfort did you experience during the procedure?" A visual analog scale will be used ranging from 0 to 10 with higher numbers indicating more pain.
Time frame: 1 day
Adequacy of Sedation
Adequacy of sedation as assessed by the previously validated PROcedural Sedation Assessment Survey (PROSAS) questionnaire \[Leffler, et al. Gastrointest Endosc. 2015;81(1):194-203\]. The patient will answer the question "If having this procedure again in the future, how much sedation would you prefer to have?" A visual analog scale will be used ranging from -5 to 5, with lower numbers indicating a preference for less sedation in the future and higher numbers indicating a preference for more sedation in the future.
Time frame: 1 day
Patient Reported Nausea
Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?"
Time frame: 1 day
Adverse Events
Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
Time frame: 1 day
Cecal Intubation Rate
cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
Cecal Intubation Time
time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
Colonoscopy Withdrawal Time
Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
Adenoma Detection Rate
Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review
Time frame: through study completion, an average of 1 year
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