Clinical exploratory study of new sedative drug for ERCP

JRCT ID: jRCTs051230088

Registered date:21/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Hepatobiliary pancreatic disorder
• Date of first enrollment: 14/11/2023
• Target sample size: 96
• Study type: Interventional
• Intervention(s): Administer remimazolam as a sedative drug during ERCP

Outcome(s)

• Primary Outcome: Success rate of sedation in ERCP

Secondary Outcome

(1)Percentage of subjects who achieved adequate sedation before starting ERCP
(2)Time from administration of remimazolam to sedation
(3)Remimazolam total dose (initial dose, additional dose)
(4)Types and doses of analgesics/sedatives other than remimazolam
(5)Sedation score during ERCP
(6)Evaluation of alertness score
(7)Satisfaction evaluation by patients and examination doctors
(8)Evaluation items related to ERCP (procedure details, complications)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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.

Exclude criteria

(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

Related Information

• Primary Sponsor: Inatomi osamu