UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051565 |
|---|---|
| Receipt number | R000058832 |
| Scientific Title | A Retrospective Comparative Study of the Frequency of Hypotension in Pediatric Cardiac Catheterization under General Anesthesia: Remimazolam vs Sevoflurane |
| Date of disclosure of the study information | 2023/07/10 |
| Last modified on | 2025/01/09 20:19:15 |
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Basic information
Public title
A Retrospective Comparative Study of the Frequency of Hypotension in Pediatric Cardiac Catheterization under General Anesthesia: Remimazolam vs Sevoflurane
Acronym
A Retrospective Comparative Study of the Frequency of Hypotension in Pediatric Cardiac Catheterization under General Anesthesia: Remimazolam vs Sevoflurane
Scientific Title
A Retrospective Comparative Study of the Frequency of Hypotension in Pediatric Cardiac Catheterization under General Anesthesia: Remimazolam vs Sevoflurane
Scientific Title:Acronym
A Retrospective Comparative Study of the Frequency of Hypotension in Pediatric Cardiac Catheterization under General Anesthesia: Remimazolam vs Sevoflurane
Region
| Japan |
Condition
Condition
Congenital Heart Disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to determine whether remimazolam reduces the incidence of hypotension in general anesthesia for cardiac catheterization for congenital heart disease compared to sevoflurane.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
the incidence of hypotension
Key secondary outcomes
The ratio of median systolic blood pressure to preoperative systolic blood pressure.
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients under 15 years of age who underwent cardiac catheterization under general anesthesia at our hospital between March 1, 2021 and December 31, 2022.
Key exclusion criteria
Patients received general anesthesia other than remimazolam or sevoflurane, patients received remifentanil, patients of ASA-PS:4-5, and patients who underwent emergency procedures.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morimatsu |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7778
pb9b45wr@s.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuhiko |
| Middle name | |
| Last name | Shimizu |
Organization
Okayama University Hospital
Division name
Department of Anesthesiology and Resuscitology
Zip code
7008558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7778
Homepage URL
tatsuhiko_shimizu@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
None
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
| 2023 | Year | 07 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
309
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 | 06 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigators will collect the following data from medical and anesthesia records: age in months , gender, height, body weight, and American Society of Anesthesiologists Preoperative Physical Status (ASA-PS), cardiac diagnosis, type of procedure, pre-medication, vital signs before entering the room and during the procedure, Patient State index (PSi) values during the procedure, procedure time, anesthesia time and intraoperative awakening.
Management information
Registered date
| 2023 | Year | 07 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058832
