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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002891
Receipt No. 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

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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
Email 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
Email fukatash@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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