Not applicable (healthy adults)
Conditions
Interventions
Administer remimazolam besylate at the following dosage and administration:
1. Single-dose group
- Group S1: remimazolam 0.05 mg/kg is administered intravenously for 1 min
- Group S2: remimazolam 0.1
Sponsors
Goto Takashi
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy individuals (equivalent to ASA-PS class 1) 2. Sex: male 3. Age: between 18 and 45 years old 4. BMI: 18.5 kg/m2 or more, less than 30 kg/m2 5. Those who voluntarily provided written informed consent upon receiving sufficient explanation and understanding the content of the study
Exclusion criteria
Exclusion criteria: 1. Those who were deemed ineligible for the study based on the results of clinical examination, physiological examinations, electrocardiogram, pulmonary function test, and health examinations for the confirmation of participant characteristics upon screening 2. Those with more than 2.5 times higher than the upper limit of the facility criteria of the aspartate transaminase and alanine transaminase levels upon screening and total bilirubin level upon screening that was 1.5 times higher than the facility criteria 3. Those treated for severe or poorly controlled (ASA PS class 3 or greater) respiratory diseases (bronchial asthma, etc.), cardiovascular disease (hypertension, etc.), neurological disorders (convulsions, etc.), digestive diseases, liver diseases, kidney disease, hematopoietic diseases, mental illness, endocrine diseases, etc. or with a history of them who were deemed ineligible for the study for security reasons by the principal investigator or sub-investigator 4. Those with a history of oversedation or respiratory depression after the administration of benzodiazepines 5. Those with a history of hypersensitivity to benzo diazepines (study drug components) or flumazenil 6. Those with diseases in which benzodiazepines are contraindicated, such as those with acute angle closure glaucoma and myasthenia gravis, or their symptoms 7. Those with a significantly prolonged corrected QT interval (recurrence of QTc > 450 ms) seen on electrocardiogram 8. Those with Mallampati class 3 or 4 9. Those with high risk of becoming comatosed with respiratory depression due to head injury, bra in tumor, among others 10. Those without the ability to provide informed consent due to complications of dementia, etc. 11. Those with chronic or acute infection 12. Those who used benzodiazepines within 12 months before the administration of the study drug 13. Those who had blood sampling of >400 mL (including blood donation) within 3 months before the administration of the study drug, those who had blood sampling of >200 mL (including blood donation) within 1 month before the administration of the study drug, those who donated blood plasma and platelet components within 2 weeks before the administration of the study drug, or those who received blood transfusion within 3 months before the administration of the study drug 14. Those who received medication within 2 weeks before the administration of the study drug or those who were on medication 15. Those with resting SpO2 of 10 cigarettes / days) and those who did not agree to quit smoking during the study 18. Heavy drinkers (equivalent to 60 g/day of pure alcohol) or those with acute alcohol intoxication and abnormal vital signs 19. Those with complications of drug abuse and dependence and alcohol dependence or a history of them 20. Those who do excessive exercise (1 week before or during the study period) and those undergoing diet for weight control 21. Others who were determined to be ineligible for the study by the principal investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the depth of sedation due to temporal changes in MOAA/S score | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subjective and objective findings 2. Temporal changes in BIS value 3. Respiratory endpoints (1) Temporal changes in SpO2 (2) Temporal changes in EtCO2 (3) Temporal changes in respiratory rate 4. Cardiovascular endpoints (1) Temporal changes in heart rate (2) Temporal changes in blood pressure (systolic and diastolic) (3) Electrocardiogram findings 5. Onset of efficacy 6. Duration of action 7. Rate of change in psychomotor function tests 8. Rate of change in the center of gravity 9. Rate of change in tests of walking ability, dynamic balance, and agility 10. Incidence and degree of adverse event 11. Drug addiction | — |
Contacts
Public ContactTakashi Goto
Asahi University Medical and Dental Center
Outcome results
None listed