Hepatobiliary pancreatic disorder
Conditions
Interventions
Administer remimazolam as a sedative drug during ERCP
Sponsors
Inatomi osamu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate of sedation in ERCP | — |
Secondary
| Measure | Time frame |
|---|---|
| (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) | — |
Contacts
Public ContactShuhei Shintani
Shiga University of Medical science
Outcome results
None listed