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: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1)Patients with diseases requiring ERCP.
(2)Older than 18years at registration.
(3)ECOG-Performance Status is 0 or 1.
(4)45 to 80 kg for body weight, under 30kg/m2 for BMI
(5)No restrictions for Remimazolam.(allergy, acute angle-closure glaucoma, myasthenia gravis, shock, coma, acute alcoholism)
(6)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 serious complications (refer to ASA classification 3 or more)
(3)Preoperative SpO2 less than 95%
(4)Patients with drug dependence
(5)Patients who regularly use benzodiazepines
(6)Pregnant and lactating patients
(7)Patients who are deemed inappropriate as subjects by the investigator
(8)Receiving medication in another clinical study within 3 months

Related Information

• Primary Sponsor: Inatomi osamu