Tolerability of Remimazolam Versus Midazolam in EUS

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Tolerability of sedation — Tolerability of sedation will be evaluated 1 hour and 24 hours after the end of the endoscopic procedure
  Evaluated using patient-reported scale for tolerability of endoscopic procedures (PRO-STEP scale). The scale consists of questions within 2 domains and is administered to outpatients at discharge from the endoscopy unit. Domain 1 (intraprocedural) consists of 2 questions regarding discomfort/pain and awareness, whereas domain 2 (postprocedural) consists of 4 questions on pain, nausea, distention, and throat pain. All questions are scored on a Likert scale from 0 to 10. Thus, higher scores underly a worse procedural tolerability.

Trial sites (1)