UMIN-ICDS Clinical Trial

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

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

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

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.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nara Medical University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Nara Medical University

Address

840 Shijo-cho, Kashihara, Nara

Tel

0744223051

Email

nsm520102@naramed-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

10

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

NA

Registered date

2022

Year

10

Month

12

Day

Last modified on

2022

Year

10

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051614