Tokyo, March 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060835) titled 'A study comparing the required doses of two sedatives, Remimazolam and Propofol, in patients undergoing gastric endoscopy' on March 5.

Study Type: Observational

Primary Sponsor: Institute - Public Interest Incorporated Foundation Sendai City Medical Center, Sendai, Japan.

Condition: Condition - Patients undergoing esophagogastroduodenoscopy (EGD) for screening or diagnostic purposes Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - 1: To calculate the clinical equipotent dose ratio of Remimazolam (RMZ) to Propofol (PRO) in the same patients under opioid-free conditions. 2: To verify whether RMZ alone enables completion of EGD equivalent to PRO alone. 3: To evaluate differences in safety and quality of recovery. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 20 years-old = 2,000 EGD experience), or a physician whose skill level is considered equivalent to an expert, in both prior and current examinations. Key exclusion criteria - Patients with changes in ASA Physical Status (ASA PS) classification between the previous and current examinations. Patients with differences in gastric anatomy due to surgical procedures between the previous and current examinations. Patients with a history of surgical treatment of the esophagus, stomach, or duodenum. Patients undergoing upper gastrointestinal endoscopic ultrasound (EUS). Use of pharyngeal anesthesia in either the previous or current examination. Patients undergoing emergency endoscopy. Women who are pregnant or may be pregnant. Patients receiving opioids (including tramadol). Other patients judged unsuitable for the study by the attending physician. Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 02 Month 02 Day Date of IRB - 2026 Year 02 Month 19 Day Anticipated trial start date - 2026 Year 03 Month 02 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069574

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