UMIN-CTR Clinical Trial

Basic information
Public title	Prevalence of cognitive impairment before surgery and factors associated with cognitive impairment.
Acronym	Investigation of preoperative cognitive impairment
Scientific Title	Prevalence of preoperative cognitive impairment and related factors.
Scientific Title:Acronym	Prevalence of preoperative cognitive impairment and related factors.
Region	Japan

Condition
Condition	Patients 65 years and older scheduled for non-cardiac surgery under general anesthesia. Patients undergoing preoperative evaluation at the Perioperative Management Center
Classification by specialty	Surgery in general Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Preoperative cognitive decline is a risk factor for postoperative delirium and has been linked to longer hospital stays and increased mortality, and the American Geriatrics Society and the American Society of Anesthesiologists recommend preoperative cognitive screening in all patients over 65 years of age undergoing surgery (J Am Geriatr Soc 2018;66:19- 21 ASA Monitor 4 2018; 82:36-38). Although several studies have investigated the relationship between preoperative cognitive function and postoperative delirium, few reports have focused on the prevalence of preoperative cognitive decline, with a prevalence of 57.2% in patients undergoing noncardiac surgery in South Africa (Br J Anaesth 2020;125:275-81) and 16.1% in ambulatory surgery patients in the United States % (Anesth Analg 2019;129:e5-e7), respectively. These results indicate that the prevalence of preoperative cognitive decline is influenced by the environment. However, there are no reports on hospitalized patients in developed countries. Therefore, we will conduct a study to investigate the prevalence of preoperative cognitive decline in patients undergoing scheduled surgery at our hospital and to examine the factors associated with it.
Basic objectives2	Others
Basic objectives -Others	Studies to determine prevalence
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	To determine the prevalence of preoperative cognitive impairment.
Key secondary outcomes	To evaluate the correlation between cognitive function and grip strength, nutritional status, and oral frailty. To evaluate the factors associated with cognitive function. To evaluate the effect of perioperative factors on postoperative delirium and postoperative complications.

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	Patients scheduled for non-cardiac surgery under general anesthesia. Patients undergoing preoperative evaluation at the Perioperative Management Center.
Key exclusion criteria	Patients who were refused to participate in the study. Patients who have been diagnosed with dementia. Patients with limited use of their dominant hand. Patients who are unable to perform preoperative assessment due to visual or hearing impairment. Patients with inadequate preoperative assessment items will be excluded from the analysis.
Target sample size	274

Research contact person
Name of lead principal investigator	1st name Shohei Middle name Last name Nakatani
Organization	Nara Medical University
Division name	Department of Anesthesiology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Email	nsm520102@naramed-u.ac.jp

Public contact
Name of contact person	1st name Shohei Middle name Last name Nakatani
Organization	Nara Medical University
Division name	Department of Anesthesiology
Zip code	634-8522
Address	840 Shijo-cho, Kashihara, Nara
TEL	0744-22-3051
Homepage URL
Email	nsm520102@naramed-u.ac.jp

Sponsor
Institute	Nara Medical University
Institute
Department

Funding Source
Organization	None
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	Nara Medical University
Address	840 Shijo-cho, Kashihara, Nara
Tel	0744223051
Email	nsm520102@naramed-u.ac.jp

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	2022 Year 10 Month 12 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	2021 Year 07 Month 25 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 10 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2022 Year 10 Month 12 Day
Last modified on	2022 Year 10 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051614