Clinical Trial: Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design (Japan)

Tokyo, June 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061833) titled 'Impact of Changing Standard Sedation Agents on Patient Satisfaction in Endoscopic Procedures: A Comparative Study of Remimazolam and Midazolam Using an Interrupted Time Series Design' on June 8.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - National Hospital Organization Hokkaido Cancer Center

Condition: Condition - digestive tract disorder Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the changes in patient satisfaction resulting from changing the standard drug for endoscopic sedation from midazolam to remimazolam. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 1. Phase 1 (Pre-intervention / Midazolam use period) Duration: 3 weeks x 2 cycles (total 6 weeks) Target number: 50 patients Content: Midazolam will be used as the standard sedative, and data from consecutive cases will be collected as much as possible. The administration method will follow the package insert.

2. Phase 2 (Washout / Training Period) Duration: 1 week x 2 cycles (total 2 weeks) Content: Switching medications. Educating staff and familiarizing them with the administration rhythm. Data from this period will be excluded from the primary analysis.

3. Phase 3 (Post-intervention / Remimazolam use period) Duration: 3 weeks x 2 cycles (total 6 weeks) Target number: 50 patients Content: Remimazolam will be used as the standard sedative, and data from consecutive cases will be collected as much as possible. The administration method will follow the package insert.

Two cycles are planned for each phase, but if the target number of patients (described below) is not reached, up to four cycles will be permitted. However, five or more cycles will not be performed.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients scheduled for elective upper gastrointestinal endoscopy (screening) or colonoscopy (screening or cold polypectomy; CSP) 1. Men and women aged 20 years or older 2. Patients with an American Society of Anesthesiologists (ASA) preoperative condition classification of Class I to II 3. Patients who have given written informed consent to participate in this study Key exclusion criteria - 1. Patients with a history of hypersensitivity to benzodiazepine drugs. 2. Patients with severe hepatic impairment (Child-Pugh class C) or those requiring dialysis. 3. Patients with ASA classification III or higher. 4. Patients with drug dependence, organic brain damage, or diseases related to upper airway obstruction (e.g., severe obesity, micrognathia, tonsillar hypertrophy, sleep apnea syndrome). 5. Pregnant, breastfeeding, or potentially pregnant women. 6. Patients requiring emergency endoscopy. 7. Patients scheduled for procedures requiring hospitalization, such as endoscopic mucosal resection (EMR). 8. Other patients deemed unsuitable as research subjects by the attending physician. Target Size - 100

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2026 Year 04 Month 09 Day Date of IRB - 2026 Year 04 Month 10 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2026 Year 09 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070670

Disclaimer: Curated by HT Syndication.