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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026664
Receipt No. 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 2019/04/07

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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
Email 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
Email 1.2.3.doooon@gmail.com

Sponsor
Institute JAPANESE RED CROSS KUMAMOTO HOSPITAL
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 118
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
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
2019 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030513

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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