UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045095
Receipt number R000051519
Scientific Title The relationship between flotillin levels and perioperative neurocognitive disorders: prospective observational study (pilot study)
Date of disclosure of the study information 2021/08/08
Last modified on 2023/08/11 06:56:13

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Basic information

Public title

The relationship between flotillin levels and perioperative neurocognitive disorders: prospective observational study (pilot study)

Acronym

The relationship between flotillin levels and perioperative neurocognitive disorders: prospective observational study (pilot study)

Scientific Title

The relationship between flotillin levels and perioperative neurocognitive disorders: prospective observational study (pilot study)

Scientific Title:Acronym

The relationship between flotillin levels and perioperative neurocognitive disorders: prospective observational study (pilot study)

Region

Japan


Condition

Condition

cervical laminoplasty or cervical laminectomy under general anesthesia

Classification by specialty

Orthopedics Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the association between flotillin levels and perioperative neurocognitive disorders.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Neurocognitive function test (MoCA-J)

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) 65 years old and over
(2) ASA PS 1-3
(3) patients with written consent
(4) patients undergoing scheduled surgery or urgent surgery scheduled by the day before

Key exclusion criteria

(1) patients undergoing emergency surgery
(2) patients undergoing two-stage surgery
(3) patients wearing a halo-vest before surgery
(4) patients who are not able to perform neurocognitive function tests
(5) patients who are expected to have difficulty communicating after surgery due to sequelae of cerebrovascular accidents or other reasons
(6) patients positive for blood pathogens
(7) other patients judged to be inaccurate by the research group (excluded by stating the reason for exclusion)

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yoshiki
Middle name
Last name SENTO

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN

TEL

+81528515511

Email

sentoy@med.nagoya-cu.ac.jp


Public contact

Name of contact person

1st name Yoshiki
Middle name
Last name SENTO

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code

467-8601

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN

TEL

0528515511

Homepage URL


Email

sentoy@med.nagoya-cu.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Intensive Care Medicine, Nagoya City University Graduate School of Medical Sciences

Institute

Department

Personal name



Funding Source

Organization

self-procurement

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

Clinical Research Management Center, Nagoya City University Hospital

Address

1-Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, JAPAN

Tel

0528515511

Email

clinical_research@med.nagoya-cu.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

2021 Year 08 Month 08 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

9

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

No longer recruiting

Date of protocol fixation

2021 Year 07 Month 08 Day

Date of IRB

2021 Year 07 Month 26 Day

Anticipated trial start date

2021 Year 07 Month 26 Day

Last follow-up date

2023 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Nil


Management information

Registered date

2021 Year 08 Month 08 Day

Last modified on

2023 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051519


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name