General anesthesia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at the time of obtaining consent is 20 years or older 2. Gender: Any 3. Patients scheduled for spinal surgery who are scheduled for general anesthesia with remimazolam 4. Patients who are scheduled to be hospitalized from at least one day before surgery to the day after the surgery 5. Patients entering the intensive care unit after scheduled surgery 6. ASA-PS (American Society of Anesthesiologist-Physical Status): 1-3 patients 7. Those who obtained consent for this research by signing the consent form
Exclusion criteria
Exclusion criteria: 1. Patients with severe respiratory, circulatory, central nervous system, digestive system, liver, kidney, hematopoietic functions, etc. 2. Emergency surgery 3. Patients scheduled to undergo surgery other than spine at the same time 4. Patients with a history of hypersensitivity to benzodiazepines or flumazenil 5. Patients with a history of hypersensitivity to remifentanil, fentanyl, rocuronium, sugammadex or other components of the drug required to maintain general anesthesia. 6. Patients with acute angle-closure glaucoma 7. Patients with myasthenia gravis 8. Shock patients, coma patients, acute alcoholics with suppressed vital signs 9. Patients who are prone to respiratory depression such as coma due to head injury or brain tumor 10. Patients with a history of seizures 11. Patients with bronchial asthma 12. Patients with organic abnormalities in the brain 13. Patients who used benzodiazepines within 1 week before surgery 14. Patients with a history of severe allergies 15. Patients who have a history of drug dependence or alcohol dependence 16. Pregnant patient 17. Lactating patients 18. Patients who are judged to have a lack of consent due to dementia and other factors 19. Patients who are judged to be excluded by other investigators/partners
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood remimazolam concentration | — |
Secondary
| Measure | Time frame |
|---|---|
| Remimazolam metabolite levels in blood, remimazolam and metabolite levels in urine | — |
Countries
Japan
Contacts
Hamamatsu University School of Medicine Department of Anesthesiology and Intensive Care Medicine