UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002891 |
|---|---|
| Receipt number | R000003526 |
| Scientific Title | A study on the prevention of postoperative delirium for the elderly |
| Date of disclosure of the study information | 2009/12/14 |
| Last modified on | 2016/02/02 13:07:48 |
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Basic information
Public title
A study on the prevention of postoperative delirium for the elderly
Acronym
A study on the prevention of postoperative delirium for the elderly
Scientific Title
A study on the prevention of postoperative delirium for the elderly
Scientific Title:Acronym
A study on the prevention of postoperative delirium for the elderly
Region
| Japan |
Condition
Condition
postoperative delirium
Classification by specialty
| Surgery in general | Psychiatry | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The puepose of this RCT study is to
make it clear whether small dose and short term Haloperidol administration after surgery is useful for the prophylaxis of postoperative delirium of the elderly persons more than 75 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We chase psychological disorders / abnormal behavior assessed with NEECHAM score from preoperative day to postoperative day 7 consecutively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, Haloperidol 2.5mg intravenous drip infusion will be performed from postoperative day 1 to day 3
Interventions/Control_2
Only serial observations will be applied to the control group
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
| 75 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
75 years or older patients with abdominal surgery or orthopedic surgery are distributed to intervention / the non-intervention group
Key exclusion criteria
A patient with emergency surgery,
or the case that haloperidol treatment intervention is performed on the 0th postoperative day (the day of operation)
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Fukata |
Organization
National Center for Geriatrics and Gerontology
Division name
Departmentof Surgery
Zip code
Address
Gengo 35, Morioka-cho, Obu-city, Aichi, Japan
TEL
0562-46-2311
fukatash@ncgg.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Fukata |
Organization
National Center for Geriatrics and Gerontology
Division name
Departmentof Surgery
Zip code
Address
Gengo 35, Morioka-cho, Obu-city, Aichi, Japan
TEL
0562-46-2311
Homepage URL
fukatash@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
(Resarch Grant for Longevity Sciences)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2009 | Year | 12 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2012 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 06 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 14 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003526
| 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 |
