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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034754
Receipt No. R000039632
Official scientific title of the study Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Date of disclosure of the study information 2018/11/02
Last modified on 2018/11/02

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Basic information
Official scientific title of the study Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Title of the study (Brief title) Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Region
Japan

Condition
Condition delirium
Classification by specialty
Neurology Geriatrics Surgery in general
Gastrointestinal surgery Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to consider whether the question in one phrase is useful for risk assessment of delirium.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Delirium based on diagnostic and statistical manual of mental disorders 4th edition text revision 5 days after surgical operation
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
65 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients aged 65 years and older scheduled to undergo surgery at our hospital
2. Patients undergoing surgery with moderate or higher invasiveness in general anesthesia
3. Patients who received written consent for participation in the study
Key exclusion criteria 1. Schizophrenia, Lewy body dementia, epilepsy, liver failure, bipolar disorder etc.
Patients with past history / comorbidities that are difficult to distinguish from delirium
2. Barbituris, benzodiazepine anxiolytic drug, zolpidem, zopiclone
Patients who are on a regular basis and are difficult to withdraw
3. Subjects who are routinely using Spoiloxant, Ramelteon and are difficult to withdraw
Four. Those who do not have TV / newspaper at home.
Five. Other patients who judged that the master / slave trial participation was difficult.
Target sample size 500

Research contact person
Name of lead principal investigator Matsumoto Yuki
Organization Southern TOHOKU General Hospital
Division name Neurology
Address Yatsuyamada 7-115, Koriyama city, Fukushima, Japan.
TEL 024-934-5322
Email yuki.matsumoto1031@gmail.com

Public contact
Name of contact person Matsumoto Yuki
Organization Southern TOHOKU General Hospital
Division name Neurology
Address Yatsuyamada 7-115, Koriyama city, Fukushima, Japan.
TEL 024-934-5322
Homepage URL
Email yuki.matsumoto1031@gmail.com

Sponsor
Institute Southern TOHOKU General Hospital
Institute
Department

Funding Source
Organization Southern TOHOKU General Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

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
2018 Year 11 Month 02 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 11 Month 02 Day
Anticipated trial start date
2018 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Delirium Rating Scale-Revised-98 (DRS-R98)

Management information
Registered date
2018 Year 11 Month 02 Day
Last modified on
2018 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039632

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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