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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019914
Receipt No. 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

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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
Last 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
Email seninoue@naramed-u.ac.jp

Public contact
1st 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
Email seninoue@naramed-u.ac.jp

Sponsor
Institute Department of Anesthesiology Nara Medical University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013576

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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