Tolerability of Remimazolam Versus Midazolam for Outpatient Endoscopic Ultrasound
Official title: Tolerability of Sedation With Remimazolam Versus Midazolam in Outpatients Undergoing Upper GI or Biliopancreatic Endoscopic Ultrasound in a Non-Anesthesiologist Setting: A Prospective Observational Study (REM-EUS Study)
Run by Azienda Socio Sanitaria Territoriale di Lecco · NCT07600073 · Data updated 2026-11-12
This study will see if patients tolerate an EUS procedure better with remimazolam plus fentanyl versus midazolam plus fentanyl, based on routine care.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | Azienda Socio Sanitaria Territoriale di Lecco Academic / other |
| Locations | 1 site (Lecco, Lecco) |
| Status | Recruiting |
| Started | February 1, 2026 |
| Main results expected | July 15, 2026 |
| Study ends | August 15, 2026 |
| Registry record updated | May 20, 2026 |
| Trial ID | NCT07600073 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 undergoing outpatient diagnostic EUS who are eligible for moderate sedation.
✕Probably not a fit
Patients for whom neither sedation approach provides a meaningful benefit or who experience adverse events with sedation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study of adults undergoing diagnostic EUS with moderate sedation chosen by the treating clinician. It compares patient experience, recovery, and satisfaction between remimazolam-based sedation and midazolam-based sedation in real-world practice. Outcomes include sedation effectiveness, recovery time, adverse events, operator satisfaction, costs, and patient-reported experience at 1 hour and 24 hours after the procedure. The goal is to understand tolerability and practicality of the two sedation strategies in routine GI endoscopy without randomizing or altering standard care. The setting reflects typical clinical practice in Italy, where propofol use and anesthesiologist involvement vary by case and operator preference.
Why it matters
Potential benefit: If remimazolam proves better tolerated, patients may experience improved comfort and shorter recovery after EUS.
How similar studies have gone: Prior research suggests remimazolam can offer rapid onset and favorable tolerability, but evidence in EUS settings remains limited and observational in nature.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Ospedale Alessandro Manzoni
Lecco, Lecco, Italy Recruiting
Study contacts
- Study coordinator: Tommaso Pessarelli, MD
- Email: t.pessarelli@asst-lecco.it
- Phone: +393925133075
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Safety of sedation with non-anesthesiologist-administered propofol during interventional endoscopy
This study tests how safe and effective the use of propofol given by non-anesthesiologists is during interventional gastrointestinal endoscopy for adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.