UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055590 |
|---|---|
| Receipt number | R000063526 |
| Scientific Title | The effect of remimazolam used for rapid induction in general anesthesia for open chest cardiac surgery on circulatory dynamics |
| Date of disclosure of the study information | 2025/01/05 |
| Last modified on | 2024/09/23 13:57:51 |
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Basic information
Public title
The effect of remimazolam used for rapid induction in general anesthesia for open chest cardiac surgery on circulatory dynamics
Acronym
The effect of remimazolam used for rapid induction in general anesthesia for open chest cardiac surgery on circulatory dynamics
Scientific Title
The effect of remimazolam used for rapid induction in general anesthesia for open chest cardiac surgery on circulatory dynamics
Scientific Title:Acronym
The effect of remimazolam used for rapid induction in general anesthesia for open chest cardiac surgery on circulatory dynamics
Region
| Japan |
Condition
Condition
angina pectoris, thoracic and abdominal aortic aneurysms, mitral regurgitation, mitral stenosis, aortic stenosis, aortic regurgitation, tricuspid regurgitation.
Classification by specialty
| Vascular surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test whether there is a significant difference in the degree of blood pressure reduction between midazolam and remimazolam drugs used for anaesthetic induction in open heart surgery with patients with reduced cardiac function.
If there is a significant difference, the patient will benefit as the drug with lower blood pressure reduction can be selected for induction.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean blood pressure values after rapid induction
Key secondary outcomes
Pulse rate, SpO2 and rSO2 before and after rapid induction
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
| 20 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Men and women aged between 20 and 90 years who visited the cardiovascular surgery department of the hospital between April 2023 and December 2025 are eligible. Among them, those determined to have either valvular disease requiring open heart surgery, thoracic or abdominal aortic aneurysm or ischaemic heart disease.
Key exclusion criteria
Under 20 years of age or over 90 years of age, with congenital heart disease, and other cases deemed inappropriate by the physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | TORU |
| Middle name | |
| Last name | MATSUOKA |
Organization
University of Yamanashi Hospital
Division name
Department of Anaesthesiology
Zip code
409-3898
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture
TEL
055-273-1111
tmatsuoka@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | TORU |
| Middle name | |
| Last name | MATSUOKA |
Organization
University of Yamanashi Hospital
Division name
Department of Anesthesiology
Zip code
409-3898
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture
TEL
055-273-1111
Homepage URL
tmatsuoka@yamanashi.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, University of Yamanashi Hospital
Institute
Department
Personal name
Funding Source
Organization
non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Yamanashi Ethics Committee
Address
1110 Shimokato, Chuo City, Yamanashi Prefecture
Tel
055-273-1111
tmatsuoka@yamanashi.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
| 2025 | Year | 01 | Month | 05 | 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
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing of note
Management information
Registered date
| 2024 | Year | 09 | Month | 23 | Day |
Last modified on
| 2024 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063526
