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Elucidation of pharmacokinetics at the end of remimazolam administratoin

Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam - Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000041438
Enrollment
40
Registered
2020-08-17
Start date
2020-08-18
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anesthesia

Interventions

General anesthesia with continuous administration of remimazolam

Sponsors

Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

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

MeasureTime frame
Blood remimazolam concentration

Secondary

MeasureTime frame
Remimazolam metabolite levels in blood, remimazolam and metabolite levels in urine

Countries

Japan

Contacts

Public ContactYuji SUZUKI

Hamamatsu University School of Medicine Department of Anesthesiology and Intensive Care Medicine

suzukiy@hama-med.ac.jp053-435-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026