Examination of pharmacokinetics in continuous administration of Remimazolam

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041200076

Enrollment

Registered

2020-12-15

Start date

2021-01-18

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

none

Interventions

Continuous administration of Remimazolam for patients undergoing mechanical ventilation and sedation management in the intensive care unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age at the time of consent is 20 years or older 2. Gender: No matter 3. Patients receiving treatment in the intensive care unit after surgery or in the state of mechanical ventilation management / sedation 4. Patients whose mechanical ventilation management / sedation period is expected to exceed 24 hours at the time of registration 5. Persons who have obtained consent for this research by signing a consent form by the person or a substitute.

Exclusion criteria

Exclusion criteria: 1. Patients with serious respiratory, circulatory, central nervous system, digestive system, liver, kidney, hematopoietic function, etc., who are the subject of this study for safety reasons Patients judged to be inappropriate 2. Patients with a history of hypersensitivity to benzodiazepines or flumazenil 3. Patients with a history of hypersensitivity to remifentanil, fentanyl, rocuronium, sugammadex or other components of the drug required to maintain general anesthesia 4. Patients with acute angle-closure glaucoma 5. Patients with myasthenia gravis 6. Patients with coma, patients with acute alcohol intoxication with suppressed vital signs 7. Patients who are prone to respiratory depression such as coma due to head trauma or brain tumor 8. Patients with a history of seizures 9. Patients with bronchial asthma 10. Patients with organic brain abnormalities 11. Patients with or with a history of drug or alcohol dependence 12. Pregnant patients 13. Patients who are judged to be incapable of consent due to complications of dementia, etc. 14. Other patients who are judged to be excluded by the investigator / shared doctor

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of Remimazolam	—

Secondary

Measure	Time frame
lood remi-mazolam metabolite concentration Urinary remimazolam and metabolite concentrations	—

Contacts

Public ContactSuzuki Yuji

Hamamatsu University Hospital

suzukiy@hama-med.ac.jp+81-53-435-2738

Outcome results

None listed

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