UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011480 |
|---|---|
| Receipt number | R000013436 |
| Scientific Title | Standardization of Management during Pediatric Sedation for MRI : A Prospective Observational Study |
| Date of disclosure of the study information | 2013/08/14 |
| Last modified on | 2015/02/16 18:52:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study
Acronym
Standardization of Management during Pediatric Sedation for MRI
Scientific Title
Standardization of Management during Pediatric Sedation for MRI
: A Prospective Observational Study
Scientific Title:Acronym
Standardization of Management during Pediatric Sedation for MRI
Region
| Japan |
Condition
Condition
Infants and children who need sedation for MRI
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the efficacy of our protocol, which includes well-designed sedation regimes using oral triclofos sodium or rectal chloral hydrate and intravenous midazolam offered with risk management plans. Thereby, we are going to establish standardized sedation regimes and risk management systems including monitoring during pediatric sedation for MRI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of successful sedation, which defined the number of successful sedation cases divided by all cases.
Criteria of the successful sedation
Little of no motion artifacts on the images judged by radiologists.
Completion of MRI within the maximum dosage of the sedative protocol.
Key secondary outcomes
The rate of successful sedation during the length of normal MRI examination, which we set 40 minutes.
Adverse events during sedation.
Dosages of sedatives, time from the administration of sedatives until the completion of the adequate sedation, the time to return to the normal state of awareness.
The delay of the start of MRI from the scheduled time.
The rate of acceptable images, which defined the number of acceptable sequences divided by the number of all sequences.
Possible correlation between successful sedation and patient characteristics
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
| 0 | years-old | <= |
Age-upper limit
| 6 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who require sedation for MRI judged by their doctors.
Informed written consent from the legal representatives for the participation of the study.
Key exclusion criteria
1 Class3 or 4 in ASA-Physical status
2 Class3 or 4 in Mallampaticlassification
3 Patients who have underlying disease with airway abnormality.
4 Patients with acute respiratory infection
5 Patients with known allergy to benzodiazepines or flumazenil
6 Patients on regular benzodiazepines
7 Previous participation of the study.
8 Patients who are assessed inappropriate for the study judged by the doctor in charge.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiro Hasegawa |
Organization
Tokyo Metropolitan Childrens' Medical Center
Division name
General Medicine
Zip code
Address
2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN
TEL
042-300-5111
yukihiro_hasegawa@tmhp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuto Takahashi |
Organization
Tokyo Metropolitan Childrens' Medical Center
Division name
General Medicine
Zip code
Address
2-8-29,Musashidai,Fuchu-city,Tokyo Metropolice,183-8561,JAPAN
TEL
042-300-5111
Homepage URL
http://www.byouin.metro.tokyo.jp/shouni/tiken/index_rinshoukenkyu.html
takuto_takahashi@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Childrens' Medical Center
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Childrens' Medical Center
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
東京都立小児総合医療センター(東京都)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 14 | 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
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 05 | 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
| 2013 | Year | 08 | Month | 13 | Day |
Last modified on
| 2015 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013436
