Tokyo, May 21 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061643) titled 'Efficacy and Safety of Remimazolam Sedation in Outpatient Endoscopic Ultrasonography: A Multicenter Randomized Controlled Trial' on May 21.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Clinical Research Center, Yokohama Rosai Hospital, Japan Organization of Occupational Health and Safety

Condition: Condition - Pancreatobiliary diseases Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy and safety of remimazolam sedation for outpatient pancreatobiliary endoscopic ultrasonography (EUS) in a multicenter randomized trial. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will be randomly assigned to receive midazolam intravenously, and outpatient pancreatobiliary endoscopic ultrasonography (EUS) will be performed under sedation. Interventions/Control_2 - Participants will be randomly assigned to receive remimazolam intravenously, and outpatient pancreatobiliary endoscopic ultrasonography (EUS) will be performed under sedation.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key 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. Key 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. Target Size - 220

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 19 Day Date of IRB - 2026 Year 05 Month 19 Day Anticipated trial start date - 2026 Year 05 Month 22 Day Last follow-up date - 2029 Year 01 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070529

Disclaimer: Curated by HT Syndication.