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)

Background Digestive endoscopy is typically performed under moderate (conscious) sedation, which does not require anesthesiologist involvement, or deep sedation, usually requiring anesthetic support. Deep sedation is often reserved for lengthy, complex, or therapeutic procedures. Effective sedation in digestive endoscopy is crucial for improving procedural quality, which in turn enhances diagnostic yield, therapeutic effectiveness, and patient tolerability.

For moderate sedation, benzodiazepines (e.g., midazolam) are frequently combined with opioids (e.g., fentanyl citrate or meperidine). While propofol is widely used for sedation in digestive endoscopy, its use is often restricted to anesthesiologist-supported procedures due to risks such as respiratory depression. Despite evidence supporting the safe administration of propofol by non-anesthesiologists, this practice remains controversial, particularly in Italy, where a minority of endoscopists administer propofol with nurse assistance, without an anesthesiologist.

Remimazolam (REM), a benzodiazepine derivative approved in the EU in August 2021 for GI endoscopy and bronchoscopy sedation, offers a rapid onset, short duration, and reversibility with flumazenil, positioning it as a promising alternative. Early trials suggest REM may achieve adequate sedation, shorter initiation times, and fewer adverse events than midazolam or propofol, though multiple doses may be necessary due to its short action. Thus, REM is currently used in many centres for sedation in digestive endoscopy. EUS, which provides high-resolution imaging of the gastrointestinal tract, is increasingly important in diagnosing and managing GI and pancreatic conditions. Diagnostic EUS, being brief and generally safe, may be well-suited to REM sedation, although data on REM's tolerability in this context remain limited and mainly focused on demonstrating comparable safety between REM and other sedatives.

Main aim To observe and compare patient-reported tolerability of remimazolam versus midazolam (both with fentanyl) in outpatient diagnostic EUS.

Secondary aims