UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061214 |
|---|---|
| Receipt number | R000069910 |
| Scientific Title | Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/09 15:31:51 |
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Basic information
Public title
Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study
Acronym
Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study
Scientific Title
Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study
Scientific Title:Acronym
Changes in Plasma Remimazolam Concentrations During Cardiac Surgery with Cardiopulmonary Bypass: A Prospective Study
Region
| Japan |
Condition
Condition
Patients undergoing cardiac surgery using cardiopulmonary bypass
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the changes in plasma remimazolam concentrations during cardiac surgery with cardiopulmonary bypass.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in Plasma Remimazolam Concentrations
Key secondary outcomes
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective cardiac surgery with cardiopulmonary bypass
Patients aged 18 years or older at the time of obtaining informed consent
Patients who have sufficient capacity to understand the study and from whom written informed consent has been obtained
Key exclusion criteria
Emergency surgery
Major vascular surgery
Redo surgery
Patients with a known allergy to remimazolam
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | masaki |
| Middle name | |
| Last name | yoshida |
Organization
wakayama medical university hospital
Division name
clinical engineering center
Zip code
641-8510
Address
811-1 kimiidera, wakayama-shi, wakayama perfecture, japan
TEL
073-447-2300
y-masaki@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | masaki |
| Middle name | |
| Last name | yoshida |
Organization
wakayama medical university hospital
Division name
clinical engineering center
Zip code
641-8510
Address
811-1 kimiidera, wakayama-shi, wakayama perfecture, japan
TEL
073-447-2300
Homepage URL
y-masaki@wakayama-med.ac.jp
Sponsor or person
Institute
wakayama medical university
Institute
Department
Personal name
masaki yoshida
Funding Source
Organization
N/A
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
Research Ethics Committee of Wakayama Medical University
Address
811-1 Kimiidera, Wakayama, Japan
Tel
+81-73-447-2300
wa-rinri@wakayama-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
和歌山県立医科大学附属病院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a single center prospective observational study conducted at Wakayama Medical University Hospital.
Adult patients 18 years or older undergoing elective cardiac surgery with cardiopulmonary bypass will be enrolled after obtaining written informed consent. No intervention will be performed and anesthesia management including the administration of remimazolam will be conducted according to standard clinical practice at the discretion of the attending anesthesiologist.
Arterial blood samples will be collected at six predefined time points before anesthesia induction before initiation of cardiopulmonary bypass after initiation of cardiopulmonary bypass after aortic cross clamping after aortic unclamping after weaning from cardiopulmonary bypass and after completion of modified ultrafiltration. In addition ultrafiltrate samples will be collected during modified ultrafiltration.
The primary outcome is the change in plasma remimazolam concentration over time during cardiopulmonary bypass.
Management information
Registered date
| 2026 | Year | 04 | Month | 09 | Day |
Last modified on
| 2026 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069910
