UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041438 |
|---|---|
| Receipt number | R000047197 |
| Scientific Title | Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam |
| Date of disclosure of the study information | 2020/08/17 |
| Last modified on | 2024/08/20 09:12:00 |
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Basic information
Public title
Elucidation of pharmacokinetics at the end of remimazolam administratoin
Acronym
Elucidation of pharmacokinetics at the end of remimazolam administratoin
Scientific Title
Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam
Scientific Title:Acronym
Elucidation of pharmacokinetics of remimazolam and metabolites before and after continuous administration of remimazolam
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetics of remimazolam at the end of continuous administration
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood remimazolam concentration
Key secondary outcomes
Remimazolam metabolite levels in blood, remimazolam and metabolite levels in urine
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia with continuous administration of remimazolam
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | SUZUKI |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
TEL
053-435-2111
suzukiy@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | SUZUKI |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
4313192
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
TEL
053-435-2111
Homepage URL
suzukiy@hama-med.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Intensive Care Medicine, Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
Tel
053-435-2680
rinri@hama-med.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 17 | Day |
Last modified on
| 2024 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047197
