Tokyo, March 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061099) titled 'Comparison of Sedation Outcomes and Discharge Criteria Between Remimazolam and Flunitrazepam in Outpatient Gastrointestinal Endoscopy: A Prospective Observational Study' on March 30.
Study Type:
Observational
Primary Sponsor:
Institute - Imagawa Medical Clinic
Condition:
Condition - Gastrointestinal diseases requiring upper or lower endoscopy (e.g., gastroesophageal reflux disease, atrophic gastritis, gastric cancer, colorectal cancer, colorectal polyps)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy and safety of the novel sedative remimazolam for outpatient gastrointestinal endoscopy, with a focus on recovery time and discharge readiness.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - 18
years-old
=
Gender - Male and Female
Key inclusion criteria - Consecutive participants aged >= 18 years undergoing upper gastrointestinal endoscopy (EGD) or colonoscopy (CS) under sedation at our clinic who provide written informed consent to this study.
Key exclusion criteria - Known allergy or hypersensitivity to the study drugs
Poor general condition classified as ASA Physical Status Class IV or V
Pregnancy or breastfeeding
Severe COPD or obstructive sleep apnea; severe hepatic impairment (e.g., Child-Pugh C); chronic benzodiazepine use or tolerance; severe renal impairment (eGFR < 30 mL/min/1.73 m^2)
Unable or unwilling to provide written informed consent to this study
Target Size - 140
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 17 Day
Date of IRB - 2025 Year 11 Month 14 Day
Anticipated trial start date - 2025 Year 11 Month 19 Day
Last follow-up date - 2025 Year 11 Month 19 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068201
Disclaimer: Curated by HT Syndication.
