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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006746
Receipt No. R000007970
Scientific Title Melatonin agonist for prevention of postoperative delirium
Date of disclosure of the study information 2011/11/18
Last modified on 2011/11/18

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Basic information
Public title Melatonin agonist for prevention of postoperative delirium
Acronym Melatonin agonist for prevention of postoperative delirium
Scientific Title Melatonin agonist for prevention of postoperative delirium
Scientific Title:Acronym Melatonin agonist for prevention of postoperative delirium
Region
Japan

Condition
Condition elective surgery
Classification by specialty
Anesthesiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine whether ramelteon can prevent postoperative delirium.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative delirium
Key secondary outcomes postoperative quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 ramelteon
Interventions/Control_2 placebo
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
70 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria elective suregery ( Knee or Hip)
Key exclusion criteria past history of psychiatric disorder
dementia
dysphagia
Target sample size 76

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshikazu Yamaguchi
Organization Yokohama city university
Division name school of medicine, department of anesthesiology and critical care medicine
Zip code
Address 3-9 Fukura, Kanazawa-ku, Yokohama, 236 JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yokohama city university
Division name school of medicine, department of anesthesiology and critical care medicine
Zip code
Address 3-9 Fukura, Kanazawa-ku, Yokohama, 236 JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Yokohama city university school of medicine, department of anesthesiology and critical care medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2011 Year 11 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 Enrolling by invitation
Date of protocol fixation
2011 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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
2011 Year 11 Month 18 Day
Last modified on
2011 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007970

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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