UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051756 |
|---|---|
| Receipt number | R000058929 |
| Scientific Title | Effects of first-generation antihistamine on emergence agitation or delirium: A Systematic Review and Meta-analysis |
| Date of disclosure of the study information | 2023/07/31 |
| Last modified on | 2024/03/07 04:19:29 |
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Basic information
Public title
Effects of first-generation antihistamine on emergence agitation or delirium: A Systematic Review and Meta-analysis
Acronym
Effects of first-generation antihistamine on emergence agitation or delirium
Scientific Title
Effects of first-generation antihistamine on emergence agitation or delirium: A Systematic Review and Meta-analysis
Scientific Title:Acronym
Effects of first-generation antihistamine on emergence agitation or delirium: A Systematic Review and Meta-analysis
Region
| Japan |
Condition
Condition
Patients with emergence agitation or delirium
Classification by specialty
| Psychiatry | Anesthesiology | Emergency medicine |
| Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the effects of first-generation antihistamines in emergence agitation or delirium
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
emergence agitation or delirium
Key secondary outcomes
Adverse events
Base
Study type
Others,meta-analysis etc
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients using first-generation antihistamines
Patients undergoing surgery or admitted to an emergency center or intensive care unit
Key exclusion criteria
When concomitant medications are different in each group
Delirium in a general ward
Children under 12 years old
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kotake |
Organization
Okayama Saiseikai General Hospital
Division name
Department of pharmacy
Zip code
700-8511
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
TEL
086-252-2211
kottanketty@gmail.com
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Kotake |
Organization
Okayama Saiseikai General Hospital
Division name
Department of pharmacy
Zip code
700-8511
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
TEL
086-252-2211
Homepage URL
kottanketty@gmail.com
Sponsor or person
Institute
Okayama Saiseikai General Hospital
Institute
Department
Personal name
Kazumasa Kotake
Funding Source
Organization
Okayama Saiseikai General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayamasaiseikai General Hospital Institutional review board
Address
2-25, Kokutai-cho, Kita-ku, Okayama City, Okayama
Tel
086-252-2211
chiken-hp@okayamasaiseikai.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
| 2023 | Year | 07 | Month | 31 | 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
| 2023 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Primary endpoints
Onset of agitation or delirium (binary variable)
Change in scale of agitation or delirium (continuous variable)
Secondary endpoints
Adverse events
Management information
Registered date
| 2023 | Year | 07 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058929
