UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035695 |
|---|---|
| Receipt number | R000040659 |
| Scientific Title | Preventive effects of ramelteon on postoperative delirium after elective liver resection |
| Date of disclosure of the study information | 2019/01/31 |
| Last modified on | 2019/01/28 12:05:37 |
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Basic information
Public title
Preventive effects of ramelteon on postoperative delirium after elective liver resection
Acronym
Preventive effects of ramelteon on postoperative delirium after elective liver resection
Scientific Title
Preventive effects of ramelteon on postoperative delirium after elective liver resection
Scientific Title:Acronym
Preventive effects of ramelteon on postoperative delirium after elective liver resection
Region
| Japan |
Condition
Condition
postoperative delirium after liver resection
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine whether ramelteon is effective for the prevention of delirium in elective liver resection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of postoperative delirium
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent liver resection at Nara Medical University (Nara, Japan) from January 2014 to August 2018 were retrieved.
Key exclusion criteria
Patients who could not take water or medicine on POD 1 were excluded.
Target sample size
306
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokuto |
Organization
Nara Medical University
Division name
Department of surgery
Zip code
Address
840 shijyo-cho, Kashihara city, Nara, Japan
TEL
0744223051
hokuto@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Hokuto |
Organization
Nara Medical University
Division name
Department of surgery
Zip code
Address
840 shijyo-cho, Kashihara city, Nara, Japan
TEL
0744223051
Homepage URL
hokuto@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Nara Medical University
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
| 2019 | Year | 01 | Month | 31 | 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
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 09 | 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
Patients who underwent liver resection at Nara Medical University (Nara, Japan) from January 2014 to August 2018 were retrieved. During the period from January 2017 to August 2018, ramelteon was prospectively administered to patients undergoing liver resection (ramelteon group), whereas ramelteon was not administered during the period from January 2014 to December 2016 (control group). The perioperative outcomes of the ramelteon group and the control group were compared.
Management information
Registered date
| 2019 | Year | 01 | Month | 28 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040659
