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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028436
Receipt No. R000032553
Scientific Title The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Date of disclosure of the study information 2017/07/29
Last modified on 2018/07/31

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Basic information
Public title The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Acronym The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Scientific Title The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Scientific Title:Acronym The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly: a randomized placebo controlled trial
Region
Japan

Condition
Condition postoperative delirium
Classification by specialty
Geriatrics Psychiatry Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference in the incidence of delirium as determined by Diagnostic and Statistical Manual of Mental Disorders, version 5 criteria between the placebo and ramelteon groups from postoperative day 0 to 6
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 Patients take 8 mg ramelteon for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
Interventions/Control_2 Patients take matching lactose for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria American Society of Anesthesiologists physical status 1,2,or 3 and scheduled to undergo general surgery or urological surgery under general anesthesia.
Key exclusion criteria Patients who are delirious on registry
Patients who are currently taking ramelteon
Patients who have a previous adverse reaction to ramelteon
Patients who take medicine contraindicated to be coadministered with ramelteon
Patients with lactose intolerance
Patients who are considered non per os on postoperative day 1
Patients who are considered to be discharged within postoperative day 6
Patients who have a score less than or equal to 10 on the Mini Mental State Examination
Patients who have severe hepatic damage
Patients with known Dementia with Lewy bodies
Target sample size 108

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Ogura
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Department of Anesthesiology
Zip code
Address 35-2 Sakaecho Itabashi-ku, Tokyo
TEL 03-3964-1141
Email ogura@tmghig.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mariko Kinouchi
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Division name Department of Anesthesiology
Zip code
Address 35-2 Sakaecho Itabashi-ku, Tokyo
TEL 03-3964-1141
Homepage URL
Email mariko2390@yahoo.co.jp

Sponsor
Institute Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Institute
Department

Funding Source
Organization Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Organization
Division
Category of Funding Organization Local Government
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 東京都健康長寿医療センター

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 29 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 Preinitiation
Date of protocol fixation
2017 Year 03 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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
2017 Year 07 Month 29 Day
Last modified on
2018 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032553

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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