Overview

Sedation Regimens in GI Endoscopy

Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Greg S Cohen MD LLC
Treatments:
Midazolam
Criteria
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