UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001039 |
|---|---|
| Receipt number | R000001247 |
| Scientific Title | A randomized placebo-controlled study of small dose and short duration Haloperidol prophylaxis for elderly at risk for postoperative delirium. |
| Date of disclosure of the study information | 2008/02/18 |
| Last modified on | 2008/02/18 17:25:26 |
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Basic information
Public title
A randomized placebo-controlled study of small dose and short duration Haloperidol prophylaxis for elderly at risk for postoperative delirium.
Acronym
RCT study of Haloperidol for postoperative delirium
Scientific Title
A randomized placebo-controlled study of small dose and short duration Haloperidol prophylaxis for elderly at risk for postoperative delirium.
Scientific Title:Acronym
RCT study of Haloperidol for postoperative delirium
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 that small dose and short duration Haloperidol administration is useful for the prophylaxis of postoperative delirium of the high risk elderly group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Behavioral and psychological disorders assessed with NEECHAM score will purchased from preoperative day to 7 days after operation 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
Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Haloperidol 2.5mg will administrated with drip infusion for 3 days after operation in the intervention group. No treatment will be applied to the control group.
Interventions/Control_2
No treatment 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
The NEECHAM score under 27 points or MMSE under 25 points are distributed to intervention and non-intervention group.
Key exclusion criteria
Emergency surgery. Case of having done treatment intervention on the 0th day (that day of operation) of after the operation.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junichi Kamiya |
Organization
Aichiken-Kouseiren-Toyota-Kousei Hospital
Division name
department of surgery
Zip code
Address
Ibohara 500-1, Jousui, Toyota city, Aichi
TEL
0565-31-1511
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideyuki Hattori |
Organization
National Hospital for Geriatrics Medicine
Division name
Department of Psychiatry
Zip code
Address
Gengo 36-3, Morioka, Obu city, Aichi
TEL
0562-46-2311
Homepage URL
Sponsor or person
Institute
National Hospital for Geriatrics Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
| 2008 | Year | 02 | Month | 18 | 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
Date of protocol fixation
| 2007 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 02 | Month | 18 | Day |
Last modified on
| 2008 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001247
| 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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