Tolerability of Remimazolam Versus Midazolam in EUS

Recruiting now

Conditions studied: Sedation During GI Endoscopy

In brief

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.

Key facts

Study ID

NCT07600073

Run by

Azienda Socio Sanitaria Territoriale di Lecco

People needed

126

Starts

2026-02-01

Expected to finish

2026-08-15

Last updated by the study team

2026-05-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Outpatients undergoing diagnostic EUS (upper GI or biliopancreatic)
• Informed consent obtained

You may not qualify if…

• Known allergy to study medications
• Recent upper respiratory infection or asthma attack
• History of sedative or opioid addiction
• Advanced oncologic disease with peritoneal metastases
• ASA score ≥ IV

Where it is running

• Ospedale Alessandro Manzoni — Lecco, Lecco, Italy (enrolling)

Full record on ClinicalTrials.gov

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