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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
