NCT04807101

Sedation Regimens in GI Endoscopy

A Randomized Study of Midazolam and Fentanyl Versus Midazolam Alone for Sedation in Gastrointestinal Endoscopy

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Greg S Cohen MD LLC · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Anesthesia
• Endoscopy
• Colonoscopy
• Conscious Sedation

Interventions

Type	Name	Description
DRUG	midazolam alone	elimination of fentanyl from conscious sedation

Timeline

• Start date: 2021-04-05
• Primary completion: 2023-07-10
• Completion: 2023-07-10
• First posted: 2021-03-19
• Last updated: 2024-04-15
• Results posted: 2024-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study