Tokyo, March 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060864) titled 'Effect of Antipsychotic Medication on Remimazolam Sedation During Gastrointestinal Endoscopy' on March 9.

Study Type: Observational

Primary Sponsor: Institute - Asakayama general hospital

Condition: Condition - Sedation during gastrointestinal endoscopy Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to evaluate the effectiveness and safety of remimazolam sedation in patients receiving antipsychotic medications undergoing gastrointestinal endoscopy. We will compare sedation success rate, total dose of remimazolam, and incidence of adverse events between patients taking antipsychotic medications and those not taking them. The study aims to clarify whether antipsychotic medication independently affects the sedative efficacy of remimazolam. Basic objectives2 - Safety,Efficacy

Eligibility: Age-lower limit - 18 years-old = 18 years at the time of informed consent 3.Patients who provided written informed consent to participate in this study Key exclusion criteria - 1.History of hypersensitivity to remimazolam. 2.Acute narrow-angle glaucoma. 3.Myasthenia gravis. 4.Hemodynamically unstable patients or those with severe respiratory dysfunction. 5.ASA Physical Status >=3. 6.Alcohol dependence or habitual heavy drinking. 7.Severe cognitive impairment or acute psychiatric conditions that make sedation assessment impossible. 8.Pregnant or breastfeeding women. 9.Patients considered inappropriate for study participation by the investigator. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 01 Day Date of IRB - 2026 Year 03 Month 02 Day Anticipated trial start date - 2026 Year 03 Month 09 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069641

Disclaimer: Curated by HT Syndication.