RecruitingNot Applicable

Tolerability of Remimazolam Versus Midazolam in EUS

Italy126 participantsStarted 2026-02-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age \> 18 years * Outpatients undergoing diagnostic EUS (upper GI or biliopancreatic) * Informed consent obtained Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tolerability of sedation

Timeframe: Tolerability of sedation will be evaluated 1 hour and 24 hours after the end of the endoscopic procedure

Trial details

NCT IDNCT07600073

SponsorAzienda Socio Sanitaria Territoriale di Lecco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07-15

Contact for this trial

Tommaso Pessarelli, MD

+393925133075 t.pessarelli@asst-lecco.it

View on ClinicalTrials.gov More Sedation During GI Endoscopy trials