UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052910 |
|---|---|
| Receipt number | R000060233 |
| Scientific Title | Investigation of the Effect of Remimazolam Use on Circulatory Management in Transurethral Resection of Bladder Tumor with 5-Aminolevulinic Acid |
| Date of disclosure of the study information | 2023/11/27 |
| Last modified on | 2024/05/28 09:48:13 |
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Basic information
Public title
Investigation of the Effect of Remimazolam on Circulatory Management in Transurethral Resection of Bladder Tumor with 5-Aminolevulinic Acid
Acronym
Investigation of the Effect of Remimazolam on Circulatory Management in Transurethral Resection of Bladder Tumor
Scientific Title
Investigation of the Effect of Remimazolam Use on Circulatory Management in Transurethral Resection of Bladder Tumor with 5-Aminolevulinic Acid
Scientific Title:Acronym
Investigation of the Effect of Remimazolam on Circulatory Management in Transurethral Resection of Bladder Tumor
Region
| Japan |
Condition
Condition
Muscle layer non-invasive bladder cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate whether the risk of hypotension is reduced in patients undergoing TUR-Bt with 5-ALA oral administration under general anesthesia in the remimazolam group compared to the sevoflurane group.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intraoperative minimum mean blood pressure value and duration
Key secondary outcomes
Circulatory Agonist Usage
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
PDD-TUR-Bt cases managed with sevoflurane and remimazolam among surgeries performed between April 2019 and March 2024
Key exclusion criteria
1) TUR-Bt patients who used anesthesia maintenance drugs other than sevoflurane and remimazolam
2) TUR-Bt patients who did not use PDD
3) Patients who expressed their refusal to participate in this study through the information disclosure document
4) Other cases deemed inappropriate by the investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Anesthesiology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
katsu1484@chiba-u.jp
Public contact
Name of contact person
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Ishibashi |
Organization
Chiba University Hospital
Division name
Anesthesiology
Zip code
260-8677
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
katsu1484@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
katsu1484@chiba-u.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
| 2023 | Year | 11 | Month | 27 | 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
118
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
Completed
Date of protocol fixation
| 2023 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the difference in the degree of circulatory variability in TUR-Bt with remimazolam versus maintenance with sevoflurane. A multivariate analysis will be performed including the presence or absence of complications.
Management information
Registered date
| 2023 | Year | 11 | Month | 27 | Day |
Last modified on
| 2024 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060233
