UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046068 |
|---|---|
| Receipt number | R000052504 |
| Scientific Title | A comparison between the blood concentration of oral midazolam for the pediatric preanesthetic medication and sedative effect |
| Date of disclosure of the study information | 2021/11/15 |
| Last modified on | 2022/11/15 21:47:38 |
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Basic information
Public title
A comparison between the blood concentration of oral midazolam for the pediatric preanesthetic medication and sedative effect
Acronym
A comparison between the blood concentration of oral MDZ for the pediatric preanesthetic medication and sedative effect
Scientific Title
A comparison between the blood concentration of oral midazolam for the pediatric preanesthetic medication and sedative effect
Scientific Title:Acronym
A comparison between the blood concentration of oral MDZ for the pediatric preanesthetic medication and sedative effect
Region
| Japan |
Condition
Condition
General anesthesia cases between 6 months and 8 years old
Classification by specialty
| Anesthesiology | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the effect of oral MDZ during induction of anesthesia and correlate with blood levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedation score (Wilton's behavior score)
Midazolam blood concentration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of MDZ syrup (in-house formulation)
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
| 6 | months-old | <= |
Age-upper limit
| 8 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients receiving MDZ syrup as pre-anesthetic medication before surgery
Key exclusion criteria
Patients with a history of hypersensitivity to MDZ components or MDZ excipients
Patients who did not give consent for this study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Matsuda |
| Middle name | |
| Last name | Hiromi |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0001
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
mtdhrm0615@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Matsuda |
| Middle name | |
| Last name | Hiromi |
Organization
Kitasato University School of Medicine
Division name
Department of Anesthesiology
Zip code
252-0001
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
042-778-8111
Homepage URL
mtdhrm0615@yahoo.co.jp
Sponsor or person
Institute
Kitasato 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
Ethics Committee of Kitasato University School of Medicine Hospital
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
042-778-8111
rinri@med.kitasato-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
| 2021 | Year | 11 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
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 | 05 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 14 | Day |
Last modified on
| 2022 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052504
