Examination of pharmacokinetics in continuous administration of Remimazolam

JRCT ID: jRCTs041200076

Registered date:15/12/2020

Basic Information

• Public title: Examination of pharmacokinetics in continuous administration of Remimazolam
• Scientific title: Examination of pharmacokinetics in continuous administration of Remimazolam
• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: none
• Study type: Interventional
• Intervention(s): Continuous administration of Remimazolam for patients undergoing mechanical ventilation and sedation management in the intensive care unit
• Sample Size: 30
• Date of first enrollment: 18/01/2021
• Countries of recruitment: Japan

Outcome(s)

• Primary Outcome: Pharmacokinetics of Remimazolam

Secondary Outcome

lood remi-mazolam metabolite concentration
Urinary remimazolam and metabolite concentrations

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Matsuyuki Doi

Ethics Reviews

• Status: Approval
• Approval Date: 01/12/2020
• Contact Name: Clinical Research Review Board of Hamamatsu University School of Medicine
• Contact Address: 1-20-1 Handayama Higashi-ku Hamamatsu , Shizuoka, Japan
• Contact Phone: [phone]
• Contact Email: [e-mail]