UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026664 |
|---|---|
| Receipt number | R000030513 |
| Scientific Title | Intravenous thiamylal in pediatric sedation for MRI: A prospective observational study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/08/24 16:43:47 |
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Basic information
Public title
Intravenous thiamylal in pediatric sedation for MRI: A prospective observational study
Acronym
Intravenous thiamylal in pediatric sedation for MRI
Scientific Title
Intravenous thiamylal in pediatric sedation for MRI: A prospective observational study
Scientific Title:Acronym
Intravenous thiamylal in pediatric sedation for MRI
Region
| Japan |
Condition
Condition
children who need sedation for MRI
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of intravenous thiamylal in pediatric sedation for MRI.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of MRI under sedation
Key secondary outcomes
Sedation related adverse events
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
| 1 | months-old | <= |
Age-upper limit
| 96 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Pediatric patients who requir sedation for MRI judged by their doctors with written consent for the participation of the study by their guardians.
Key exclusion criteria
1. Patients with known allergy to barbiturates
2. Patients who have a fever over 38 degrees
3. Patients with acute respiratory infection
4. Patients who have underlying disease with airway abnormality
5. Class 3 or 4 in ASA-Physical status
6. Class 3 or 4 in Mallampati classification
7. Patients who administer medicine other than thiamylal during MRI examination
8. Previous participation of the study
9. Patients who are assessed inappropriate for the study judged by the doctor in charge
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuki |
| Middle name | |
| Last name | Hirai |
Organization
JAPANESE RED CROSS KUMAMOTO HOSPITAL
Division name
Department of pediatrics
Zip code
8618520
Address
2-1-1 Nagamine-minami, Higashi-Ku, Kumamoto City, Kumamoto
TEL
096-384-2111
1.2.3.doooon@gmail.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Irie |
Organization
JAPANESE RED CROSS KUMAMOTO HOSPITAL
Division name
Department of pediatrics
Zip code
8618520
Address
2-1-1 Nagamine-minami, Higashi-Ku, Kumamoto City, Kumamoto
TEL
096-384-2111
Homepage URL
1.2.3.doooon@gmail.com
Sponsor or person
Institute
JAPANESE RED CROSS KUMAMOTO HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
JAPANESE RED CROSS KUMAMOTO HOSPITAL
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
JAPANESE RED CROSS KUMAMOTO HOSPITAL
Address
2-1-1 Nagamine-minami, Higashi-Ku, Kumamoto City, Kumamoto
Tel
096-384-2111
rinsyoukenkyu@kumamoto-med.jrc.or.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
| 2017 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/32359890/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/32359890/
Number of participants that the trial has enrolled
118
Results
A total of 118 patients were included in the analysis with median age and weight of 31.5 months (14.0-56.8 months) and 12.6 kg (9.5-15.7 kg), respectively. The success rate of MRI was 96.6% (114/118), and the median dose of thiamylal per body weight was 3.6 (2.8-4.0) mg/kg.
Results date posted
| 2020 | Year | 08 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://pubmed.ncbi.nlm.nih.gov/32359890/
Participant flow
https://pubmed.ncbi.nlm.nih.gov/32359890/
Adverse events
https://pubmed.ncbi.nlm.nih.gov/32359890/
Outcome measures
https://pubmed.ncbi.nlm.nih.gov/32359890/
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 03 | Month | 23 | Day |
Last modified on
| 2020 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030513
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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