UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006746 |
|---|---|
| Receipt number | 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 16:28:20 |
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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
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
Sponsor or person
Institute
Yokohama city university school of medicine, department of anesthesiology and critical care medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007970
