UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054224 |
|---|---|
| Receipt number | R000061915 |
| Scientific Title | Investigation of the effects of anesthetics used in cardiovascular catheterization on circulatory dynamics. |
| Date of disclosure of the study information | 2024/04/22 |
| Last modified on | 2024/04/22 17:10:45 |
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Basic information
Public title
Investigation of the effects of anesthetics used in cardiovascular catheterization on circulatory dynamics.
Acronym
Investigation of the effects of anesthetics used in cardiovascular catheterization on circulatory dynamics.
Scientific Title
Investigation of the effects of anesthetics used in cardiovascular catheterization on circulatory dynamics.
Scientific Title:Acronym
Investigation of the effects of anesthetics used in cardiovascular catheterization on circulatory dynamics.
Region
| Japan |
Condition
Condition
Patients undergoing cardiology catheterization with anesthesia-controlled ASA PS 2-4
Classification by specialty
| Cardiology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We compared the effects on hemodynamics of volatile inhalation anesthetics (sevoflurane, desflurane) and intravenous anesthetics (propofol, remimazolam), which are anesthetics used to maintain general anesthesia management for catheter treatment of valvular heart disease, and found that the effect on hemodynamics was the least circulatory depression. To investigate suitable anesthetics for catheter treatment of valvular heart disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage reduction in blood pressure drop after induction of anesthesia
Key secondary outcomes
Mean blood pressure less than 65 mmHg for time after induction of anesthesia
Percentage of time under mean blood pressure less than 65 mmHg during anesthesia
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
| 50 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing cardiology catheterization with anesthesia-controlled ASA PS 2-4
Key exclusion criteria
emergency case
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. Marianna university school of medicine
Division name
Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-Ku Kawasaki
TEL
0449778111
y2obata@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Obata |
Organization
St. marianna university school of medicine
Division name
Anesthesiology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-Ku Kawasaki
TEL
0449778111
Homepage URL
y2obata@marianna-u.ac.jp
Sponsor or person
Institute
St. marianna university school of medicine
Institute
Department
Personal name
Funding Source
Organization
St. marianna university school of medicine
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
St marianna university school of medicine
Address
St. marianna university school of medicine
Tel
0449778111
y2obata@marianna-u.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
| 2024 | Year | 04 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 04 | Month | 22 | Day |
Last modified on
| 2024 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061915
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
