Clinical exploratory study of new sedative drug for ERCP
- Conditions
- Hepatobiliary pancreatic disorder
- Registration Number
- JPRN-jRCTs051230088
- Lead Sponsor
- Inatomi osamu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 96
(1)Patients with diseases requiring ERCP.
(2)Older than 20years at registration.
(3)ECOG-Performance Status is 0 or 1.
(4)45 to 80 kg for body weight, under 30kg/m2 for BMI
(4)No restrictions for Remimazolam.(allergy, acute angle-closure glaucoma, myasthenia gravis, shock, coma, acute alcoholism)
(5)Patients who have informed consent after receiving a sufficient explanation about their participation in the study.
(1)Patients with a history of hypersensitivity to remimazolam.
(2)Patients with acute angle-closure glaucoma
(3)Patients with myasthenia gravis
(4)Patients with serious complications in other organs: ASA classification 3 or higher (excluding dialysis patients)
(5)Patients with drug dependence
(6)Patients with severe liver dysfunction (Child Pugh classification C)
(7)Patients who are pregnant or breastfeeding
(8)Other patients who are judged to be inappropriate as subjects by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of sedation in ERCP
- Secondary Outcome Measures
Name Time Method (1)Percentage of subjects who achieved adequate sedation before starting ERCP<br>(2)Time from administration of remimazolam to sedation<br>(3)Remimazolam total dose (initial dose, additional dose)<br>(4)Types and doses of analgesics/sedatives other than remimazolam<br>(5)Sedation score during ERCP<br>(6)Evaluation of alertness score<br>(7)Satisfaction evaluation by patients and examination doctors<br>(8)Evaluation items related to ERCP (procedure details, complications)