UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000038217
Receipt number R000043566
Scientific Title Relationship between preoperative Mild Cognitive Impairment and Postoperative Cognitive Decline: a prospective observational study.
Date of disclosure of the study information 2019/10/07
Last modified on 2019/10/07 11:03:04

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Basic information

Public title

Relationship between preoperative Mild Cognitive Impairment and Postoperative Cognitive Decline: a prospective observational study.

Acronym

Relationship between preoperative Mild Cognitive Impairment and Postoperative Cognitive Decline: a prospective observational study.

Scientific Title

Relationship between preoperative Mild Cognitive Impairment and Postoperative Cognitive Decline: a prospective observational study.

Scientific Title:Acronym

Relationship between preoperative Mild Cognitive Impairment and Postoperative Cognitive Decline: a prospective observational study.

Region

Japan


Condition

Condition

Upper 65-year-old patients who will receive general anesthesia

Classification by specialty

Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the difference between MCI patients and robust patients of the incidence of postoperative cognitive decline.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

MoCA-J score of pre-operative, post-operative (1 week, 3 months)

Key secondary outcomes

To compare the patients' factor, anesthetic factor, operation factor, postoperative factor, and the incidence of post operative delirium.


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 aged over 65 and scheduled for surgery under general anesthesia.
Patients who give written informed consent to participate in the study.

Key exclusion criteria

Patients who have serious audio-visual obstacles that affected communication.
Patients who underwent neurosurgery.
Patients who were judged to be inappropriate as subjects by the study investigators.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Maiko
Middle name
Last name Hosokawa

Organization

Showa University

Division name

Department of Anesthesiology

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8575

Email

maiko-hskw@med.showa-u.ac.jp


Public contact

Name of contact person

1st name Maiko
Middle name
Last name Hosokawa

Organization

Showa University

Division name

Department of Anesthesiology

Zip code

142-8666

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

TEL

03-3784-8575

Homepage URL


Email

maiko-hskw@med.showa-u.ac.jp


Sponsor or person

Institute

Showa University

Institute

Department

Personal name



Funding Source

Organization

Not applicable

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics comittee specializing in human subgects reserch at the Showa University.

Address

1-5-8 Hatanodai, Shinagawa-ku, Tokyo

Tel

03-3784-8129

Email

gakuji@ofc.showa-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

2019 Year 10 Month 07 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

Enrolling by invitation

Date of protocol fixation

2018 Year 06 Month 01 Day

Date of IRB

2018 Year 08 Month 01 Day

Anticipated trial start date

2019 Year 10 Month 07 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Patients information: age, gender, height/weight, BSA, BMI, diagnosis, operation, ASA-PS, blood test, drug, past history, FRAIL score, education level
Anesthesia record: procedure, drug, vital signs, PSI, EEG,
MoCA-J score and response time (preoperative, 1 week, 3 months after operation)
Medical record: delirium, post-operative pain (NRS)


Management information

Registered date

2019 Year 10 Month 07 Day

Last modified on

2019 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043566


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name