Tokyo, Aug. 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062607) titled 'Exploratory Analysis of Factors Influencing Optimal Bispectral Index Values During Gastrointestinal Endoscopic Sedation (BEST study)' on Aug. 18.
Study Type:
Observational
Primary Sponsor:
Institute - Aichi medical University
Condition:
Condition - Patients with suspected gastrointestinal disease who undergo esophagogastroduodenoscopy or colonoscopy
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - Using Bispectral Index (BIS) monitoring, this study aims to identify factors associated with optimal BIS values during gastrointestinal endoscopic sedation and to determine age-specific optimal BIS values.
Basic objectives2 - Pharmacokinetics
Eligibility:
Age-lower limit - 18
years-old
18 years.
Scheduled for sedated upper gastrointestinal endoscopy.
Scheduled for sedated lower gastrointestinal endoscopy.
Key exclusion criteria - Performance Status>3.
Patients with severe cardiac dysfunction(New York Heart Association Classlll or higher),pulmonary dysfunction requiring continuous of intermittent oxygen therapy,hepatic dysfunction(Child-Pugh Class C),renal dysfunction(eGFR9.0%).
Patients with glaucoma,myasthenia gravis,or alcohol intoxication/alcohol dependence.
Patients with psychiatric disorders or dementia who are considered unable to participate in the study.
Patients judged by the investigateor to be inappropriate for patricipation in the study for any reason.
Target Size - 140
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2026 Year 07 Month 28 Day
Date of IRB - 2026 Year 07 Month 30 Day
Anticipated trial start date - 2026 Year 08 Month 18 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071666
Disclaimer: Curated by HT Syndication.
