NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs041200076

Registered date:15/12/2020

Examination of pharmacokinetics in continuous administration of Remimazolam

Basic Information

Public titleExamination of pharmacokinetics in continuous administration of Remimazolam
Scientific titleExamination of pharmacokinetics in continuous administration of Remimazolam
Recruitment statusRecruiting
Health condition(s) or Problem(s) studiednone
Study typeInterventional
Phase
Study design
Intervention(s)Continuous administration of Remimazolam for patients undergoing mechanical ventilation and sedation management in the intensive care unit
Sample Size30
Date of first enrollment18/01/2021
Completion date
Countries of recruitmentJapan

Outcome(s)

Primary OutcomePharmacokinetics of Remimazolam
Secondary Outcomelood remi-mazolam metabolite concentration Urinary remimazolam and metabolite concentrations

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1. 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 criteria1. 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 SponsorMatsuyuki Doi
Secondary
Source(s)

Secondary Identifiers

Secondary ID

Contact

Public contact
Name Yuji Suzuki
Address 1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2738
E-mail suzukiy@hama-med.ac.jp
Affiliation Hamamatsu University Hospital
Scientific contact
Name Matsuyuki Doi
Address 1-20-1 Handayama Higashi-ku Hamamatsu Shizuoka Shizuoka Japan 431-3192
Telephone +81-53-435-2738
E-mail matdoi@hama-med.ac.jp
Affiliation Hamamatsu University Hospital

Ethics Reviews

StatusApproval
Approval Date01/12/2020
Contact NameClinical Research Review Board of Hamamatsu University School of Medicine
Contact Address1-20-1 Handayama Higashi-ku Hamamatsu , Shizuoka, Japan
Contact Phone+81-53-435-2680
Contact Emailkenkyou.s@hama-med.ac.jp

Summary Results

Date of posting of results summaries
Date of the first journal publication of results
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Baseline Characteristics
Participant flow
Adverse events
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Brief Summary
URL link to protocol file(s) with version and date

IPD sharing statement

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