Skip to content

Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial

Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial - Y-ROSE Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061643
Enrollment
220
Registered
2026-05-21
Start date
2026-05-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatobiliary diseases

Interventions

Participants will be randomly assigned to receive midazolam intravenously, and outpatient pancreatobiliary endoscopic ultrasonography (EUS) will be performed under sedation. Participants will be rando

Sponsors

Clinical Research Center, Yokohama Rosai Hospital, Japan Organization of Occupational Health and Safety
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients aged 18 years or older. 2.Patients scheduled to undergo outpatient EUS for evaluation of pancreatobiliary diseases. 3/Patients from whom written informed consent has been obtained.

Exclusion criteria

Exclusion criteria: 1.Patients undergoing upper gastrointestinal endoscopy on the same day as the EUS examination. 2.Patients who have already participated in this study. 3.Patients with an allergy to benzodiazepines. 4.Patients with acute angle-closure glaucoma. 5.Patients with myasthenia gravis. 6.Patients with an American Society of Anesthesiologists Physical Status (ASA-PS) classification of III or higher. 7.Pregnant or breastfeeding women. 8.Patients deemed inappropriate for participation in this study by the attending physician for any other reason.

Design outcomes

Primary

MeasureTime frame
ate of achieving a Modified Aldrete score of 9 or higher at 30 minutes after completion of the procedure

Countries

Japan

Contacts

Public ContactMasato Suzuki

Yokohama Rosai Hospital Department of Gastroenterology

d07sm056@gmail.com045-474-8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026