Endoscopy Clinical Trials

Clinical trials related to Endoscopy Procedure

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)

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \> 18 years

• Outpatients undergoing diagnostic EUS (upper GI or biliopancreatic)

• Informed consent obtained

Locations
Other Locations
Italy
Ospedale Alessandro Manzoni
RECRUITING
Lecco
Contact Information
Primary
Tommaso Pessarelli, MD
t.pessarelli@asst-lecco.it
+393925133075
Time Frame
Start Date: 2026-02-01
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 126
Treatments
Remimazolam
Patients undergoing EUS under sedation with remimazolam
Midazolam
Patients undergoing EUS under sedation with midazolam
Related Therapeutic Areas
Sponsors
Leads: Azienda Socio Sanitaria Territoriale di Lecco

This content was sourced from clinicaltrials.gov