UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007204 |
|---|---|
| Receipt number | R000008480 |
| Scientific Title | A study on the aggravation prophylaxis of postoperative delirium for the elderly |
| Date of disclosure of the study information | 2012/02/02 |
| Last modified on | 2016/08/08 08:26:02 |
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Basic information
Public title
A study on the aggravation prophylaxis of postoperative delirium for the elderly
Acronym
A study on the aggravation prophylaxis of postoperative delirium for the elderly
Scientific Title
A study on the aggravation prophylaxis of postoperative delirium for the elderly
Scientific Title:Acronym
A study on the aggravation prophylaxis 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 purpose of this RCT study is to make it clear whether Haloperidol administration from an early stage of delirium is useful for the aggravation prevention of postoperative delirium of the elderly persons more than 75 years old.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We chase psychological disorders / abnormal behavior assessment with NEECHAM score from preoperative day to postoperative day 10 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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, Haloperidol 5mg intravenous drip infusion will be performed from postoperative day 0 to 5, when the NEECHAM score is 20 to 24.
When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
Interventions/Control_2
Only serial obsevations will be applied to the control group.
When the NEECHAM score is less than 19, conventional treatment of delirium including the haloperidol intravenous drip infusion will be performed.
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 / orthopedic surgery are distributed to the intervention / non-intervention group.
Key exclusion criteria
A patient with emergency surgery.
The case whose NEECHAM score is less than 19.
Target sample size
180
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
Department of Perioperative Medical Care
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
Department of Perioperative Medical Care
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
National Center for Geriatrics and Gerontology(Independent administative agency)
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 02 | Month | 02 | 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
| 2012 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 02 | Day |
Last modified on
| 2016 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008480
