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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007204
Receipt No. 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

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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
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 Department of Perioperative Medical Care
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 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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008480

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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