UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024258 |
|---|---|
| Receipt number | R000027930 |
| Scientific Title | Preventive effects of ramelteon on delirium at post operative cardiac surgery: arandomized placebo-controlled trial |
| Date of disclosure of the study information | 2016/10/02 |
| Last modified on | 2021/04/19 09:17:45 |
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Basic information
Public title
Preventive effects of ramelteon on delirium at post operative cardiac surgery: arandomized placebo-controlled trial
Acronym
Ramelteon preventsdelirium in postoperative cardiac surgery
Scientific Title
Preventive effects of ramelteon on delirium at post operative cardiac surgery: arandomized placebo-controlled trial
Scientific Title:Acronym
Ramelteon preventsdelirium in postoperative cardiac surgery
Region
| Japan |
Condition
Condition
cardiac surgery patients
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether ramelteon, is effective for the prevention of delirium postoperatively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of delirium
Key secondary outcomes
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
to receive 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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
elective cardiac surgery patients
Key exclusion criteria
dementia
SAS
the patients not agree
severe disorder of liver function
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Aneshtesiology
Zip code
Address
1-1 Kodacho, Shunan-city 7458522, Japan
TEL
0834-22-4411
manabu-ygc@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Yoshimura |
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
Division name
Anesthesiology
Zip code
Address
1-1 Kodacho, Shunan-city 7458522, Japan
TEL
0834-22-4411
Homepage URL
manabu-ygc@umin.ac.jp
Sponsor or person
Institute
Japan Community Healthcare Organization Tokuyama Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Community Healthcare Organization Tokuyama Central Hospital
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
| 2016 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 02 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027930
