Tokyo, Nov. 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059792) titled 'A prospective observational study on remimazolam use and patient satisfaction in real-world clinical practice' on Nov. 16.
Study Type:
Observational
Primary Sponsor:
Institute - Osaka Metropolitan University
Condition:
Condition - Patients undergoing upper gastrointestinal endoscopy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - We aim to optimize safe and comfortable sedation management by evaluating real-world patterns of its use, recovery room stay and recovery time, the incidence of complications, patient satisfaction, and symptoms and interference with daily life up to the day after the procedure.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients scheduled to undergo upper gastrointestinal endoscopy using remimazolam at the study institution for screening, surveillance, or diagnostic purposes between the date of UMIN registration publication and March 2028.
2. Patients who agree to participate in the study and are 18 years of age or older at the time of obtaining informed consent.
Key exclusion criteria - 1. Patients with ASA physical status classification IV or higher
2. Patients with acute angle-closure glaucoma
3. Patients with myasthenia gravis
4. Patients with a history of allergy to any component of remimazolam
Target Size - 50
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 11 Day
Date of IRB - 2025 Year 11 Month 11 Day
Anticipated trial start date - 2025 Year 11 Month 20 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068366
Disclaimer: Curated by HT Syndication.
