None listed
Conditions
Interventions
Drug : (1) Study Drug: Remimazolam besylate 20 mg (trade name Byfavo 20 mg)
- Initial dose of 5 mg administered over 1 minute.
- Additional supplemental doses of 2.5 mg may be administered as needed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female who is at least 19 years of age and less than 65 years of age - Scheduled for a diagnostic sedative endoscopy - American Society of Anesthesiology (ASA) performance score of I or II - Voluntarily decide to participate and sign an informed consent form after receiving an explanation of the study process
Exclusion criteria
Exclusion criteria: -Anticipated difficulty with intubation (e.g., Mallampati's Class 3 or greater factor) -Have a history of breathing problems during sedation (e.g., sleep apnea, chronic obstructive pulmonary disease, severe or acute respiratory failure, or other respiratory disorder) -Hypersensitivity to remimazolam or benzodiazepine medications -Pregnant or lactating women Patients with acute narrow-angle glaucoma -Patients in shock or coma -Patients with acute alcohol intoxication with suppressed vital signs -Patients with alcohol or drug dependence -Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. -Patients with a history of severe hypersensitivity to Dextran 40 -Anyone else who is not considered appropriate to participate in the study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to fully alert;Incidence of hypotension, bradycardia, respiratory depression | — |
Secondary
| Measure | Time frame |
|---|---|
| Procedure success;Total duration of procedure | — |
Countries
Korea, Republic of
Contacts
Public ContactHaeri Jo
Asan Medical Center
Outcome results
None listed