UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042628 |
|---|---|
| Receipt number | R000048520 |
| Scientific Title | Comparison of ED95 of rocuronium between sex in children. |
| Date of disclosure of the study information | 2020/12/05 |
| Last modified on | 2023/06/07 08:22:12 |
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Basic information
Public title
Comparison of ED95 of rocuronium between sex in children.
Acronym
Comparison of ED95 of rocuronium between sex in children.
Scientific Title
Comparison of ED95 of rocuronium between sex in children.
Scientific Title:Acronym
Comparison of ED95 of rocuronium between sex in children.
Region
| Japan |
Condition
Condition
Comparison of ED95 of rocuronium between sex in children.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the appropriate dose of rocuronium by gender in children by examining gender differences in ED95 of rocuronium in 6 to 12 years old.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ED95 of rocuronium
Key secondary outcomes
Recovery time from rocuronium administration to 25%, 90%, 100% of control
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
| 6 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Children undergoing general anesthesia at the age of 6-12
2. American society of anesthesiology physical status (ASA) 1 or 2
3. Patients with written parental consent for participation in this study
Key exclusion criteria
1. Neuromuscular diseases
2. Rapid sequence induction
3. Taking any drug known to interact with neuromuscular blocking agents
4. Severe hepatic diseases
5. Dialysis patients
6. Predicted difficult airways
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Hanae |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
TEL
+81-3-3972-8111
nakamura.hanae@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Hanae |
| Middle name | |
| Last name | Sato |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
1738610
Address
+81-3-3972-8111
TEL
+81-3-3972-8111
Homepage URL
nakamura.hanae@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon University Itabashi Hospital, Clinical Research Judging Committee
Address
30-1, Oyaguchi Kamicho, Itabashi-Ku, Tokyo, Japan
Tel
+81-3-3972-8111
komoda.nozomi@nihon-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
日本大学医学部付属板橋病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 05 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary outcome is ED95 of rocuronium.
Secondary outcomes are durations of rocuronium (Recovery of twitch height from rocuronium administration to 25%, 90%, and 100% of control).
Management information
Registered date
| 2020 | Year | 12 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048520
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
