Sedation Regimens in GI Endoscopy

Early Phase 1

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

English-speaking patients
Patients ≥18 years old and ≤75 years old
Outpatients presenting for EGD and/or colonoscopy planned with conscious sedation using midazolam and fentanyl
Patients presenting for endoscopic procedures with no GI fellow or trainee involvement in the procedure

Exclusion Criteria

Patients with an allergy or prior adverse event to either fentanyl or midazolam
Patients who have previously not tolerated endoscopy with conscious sedation and require monitored anesthesia care (MAC)
Adults unable to consent
Individuals who are not yet adults (infants, children, teenagers)
Pregnant women
Prisoners
Vulnerable populations, including cognitively impaired adults and adults who are otherwise unable to consent

Arm && Interventions

Group	Intervention	Description
midazolam alone	midazolam alone	Patients in this arm will receive conscious sedation with medazepam alone

Primary Outcome Measures

Name	Time	Method
Pain Felt During the Procedure	1 day	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.
Adequacy of Sedation	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Patient Reported Nausea	1 day	Patient reported nausea as assessed by a yes or no answer to the question "Do you have any nausea now?"
Adverse Events	1 day	Oxygen desaturation, hypotension, or any other event requiring the procedure to be interrupted
Cecal Intubation Rate	through study completion, an average of 1 year	cecal intubation rate for the 2 arms of the study will be assessed by retrospective chart review
Cecal Intubation Time	through study completion, an average of 1 year	time to reach the cecum for the 2 arms of the study will be assessed by retrospective chart review
Adenoma Detection Rate	through study completion, an average of 1 year	Adenoma detection rate for the 2 arms of the study will be assessed by retrospective chart review
Colonoscopy Withdrawal Time	through study completion, an average of 1 year	Colonoscopy withdrawal time for the 2 arms of the study will be assessed by retrospective chart review