UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Acronym	Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Scientific Title	Efficacy of one-phrase question to evaluate the risk of postoperative delirium in the elderly
Scientific Title:Acronym	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	Diagnosis of delirium based on diagnostic and statistical manual of mental disorders 4th edition text revision(DSM-IV TR) for 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 take these drugs regularly and are difficult to withdraw 3. Subjects who are routinely using Suvorexant, ramelteon are difficult to withdraw 4. Those who do not have TV / newspaper at home. 5. Patients judged inappropriate by physician for other reasons.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Matsumoto
Organization	Southern TOHOKU General Hospital
Division name	Neurology
Zip code	963-8041
Address	Yatsuyamada 7-115, Koriyama city, Fukushima, Japan.
TEL	024-934-5322
Email	yuki.matsumoto1031@gmail.com

Public contact
Name of contact person	1st name Yuki Middle name Last name Matsumoto
Organization	Southern TOHOKU General Hospital
Division name	Neurology
Zip code	963-8041
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)

IRB Contact (For public release)
Organization	Institute for Neuroscience, Institutional review board
Address	Yatsuyamada 7-115, Koriyama city, Fukushima, Japan.
Tel	+81-024-934-5322
Email	yuki.matsumoto1031

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

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	Open public recruiting
Date of protocol fixation	2018 Year 11 Month 02 Day
Date of IRB	2017 Year 10 Month 31 Day
Anticipated trial start date	2018 Year 11 Month 02 Day
Last follow-up date	2023 Year 10 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Delirium Rating Scale-Revised-98 (DRS-R98)

Management information
Registered date	2018 Year 11 Month 02 Day
Last modified on	2021 Year 08 Month 17 Day

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