Tolerability of Remimazolam Versus Midazolam in EUS

This study will observe and compare patient experience during outpatient diagnostic endoscopic ultrasound (EUS) when moderate sedation is provided with either remimazolam plus fentanyl or midazolam plus fentanyl, according to routine clinical practice. Both sedation approaches are currently used in standard care. The choice of sedative will be made by the treating physician as part of usual practice and not assigned by the study. The purpose of the study is to evaluate how patients tolerate the procedure with each sedation strategy, focusing on comfort, recovery, and overall procedural experience. After the procedure, participants will be asked to complete questionnaires about their experience at 1 hour and 24 hours after EUS. The study will also collect information on sedation effectiveness, operator satisfaction, recovery time, adverse events, and costs. This is a prospective observational single-center study involving adult outpatients undergoing diagnostic EUS. Information collected during routine care, including vital signs, recovery measures, and procedural data, will be analyzed to compare outcomes between the two sedation approaches.

NCT Number	NCT07600073
Lead Sponsor	Azienda Socio Sanitaria Territoriale di Lecco
Conditions	Sedation During GI Endoscopy
Enrollment	126 participants
Start Date	2026-02-01
Primary Completion	2026-07-15 (estimated)
Study Completion	2026-08-15 (estimated)
Updated on ClinicalTrials.gov	2026-05-20