UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019914 |
|---|---|
| Receipt number | R000013576 |
| Scientific Title | The effect of sedation under mechanical ventilation on postoperative cognitive function and recovery profiles |
| Date of disclosure of the study information | 2015/11/24 |
| Last modified on | 2017/05/26 11:37:09 |
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Basic information
Public title
The effect of sedation under mechanical ventilation on postoperative cognitive function and recovery profiles
Acronym
Sedation and postoperative cognitive function
Scientific Title
The effect of sedation under mechanical ventilation on postoperative cognitive function and recovery profiles
Scientific Title:Acronym
Sedation and postoperative cognitive function
Region
| Japan |
Condition
Condition
Postoperative oral and maxillofacial surgical patients
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Effects of sedation on postoperative cognitive function
Basic objectives2
Others
Basic objectives -Others
Effects of sedation on postoperative recovery profiles
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Effects of sedation duration on postoperative cognitive function
Key secondary outcomes
Effects of sedation duration on side effects
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
| 55 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Surgical patients
Key exclusion criteria
Patients with dementia are excluded
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoki Inoue |
Organization
Nara Medical University
Division name
Division of Intensive Care
Zip code
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
seninoue@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoki Inoue |
Organization
Nara Medical University
Division name
Division of Intensive Care
Zip code
Address
840 Shijo-cho Kashihara Nara
TEL
0744-22-3051
Homepage URL
seninoue@naramed-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology 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
| 2015 | Year | 11 | Month | 24 | 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
| 2013 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 01 | Day |
Other
Other related information
Under observation
Initially, Neck, throat, and ear surgical patients should have veen enrolled; however, these patients did not need to be sedated. Thus, participants has been changed toonly oral surgical patients.
Management information
Registered date
| 2015 | Year | 11 | Month | 24 | Day |
Last modified on
| 2017 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013576
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
