UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044630 |
|---|---|
| Receipt number | R000050979 |
| Scientific Title | Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children. |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/23 13:15:18 |
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Basic information
Public title
Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Acronym
Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Scientific Title
Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Scientific Title:Acronym
Safety and efficacy of remimazolam in induction and maintenance of general anesthesia in children.
Region
| Japan |
Condition
Condition
peadatric patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating the Safety and Efficacy of Remimazolam for General Anesthesia in Children
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Drug dosage, additional intraoperative sedatives, time taken from end of administration to awakening, complications (laryngospasm, postoperative nausea and vomiting, delayed awakening)
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Child undergoing general anesthesia with remimazolam administration
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Norifumi |
| Middle name | |
| Last name | Kuratani |
Organization
Saitama Children's Medical Center
Division name
Department of Anesthesiology
Zip code
330-8777
Address
1-2 Shin-toshin, Chuo-ku, Saitama-City Saitama
TEL
048-601-2200
nori-kuratani@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Miyashita |
Organization
Saitama Red Cross Hospital
Division name
Department of Anesthesiology
Zip code
330-8553
Address
1-5 Shin-toshin, Chuo-ku, Saitama-City Saitama
TEL
048-852-1111
Homepage URL
mactak_llp@hotmail.com
Sponsor or person
Institute
Saitama Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Children's Medical Center
Address
1-2 Shin-toshin, Chuo-ku, Saitama-City Saitama
Tel
048-601-2200
mactak_llp@hotmail.com
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 | 07 | 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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We collected information from the electronic anesthesia chart (ORSYS) and the electronic medical record (MegaOak) on drug dosage, additional intraoperative sedation, time from the end of administration to awakening, and complications (laryngospasm, postoperative nausea and vomiting, and delayed awakening) in cases where remimazolam was used for general anesthesia in children. Information on these complications (laryngospasm, postoperative nausea and vomiting, delayed awakening) will be collected from the electronic anesthesia chart (ORSYS) and the electronic medical record (MegaOak).
Management information
Registered date
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2021 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050979
