UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014027 |
|---|---|
| Receipt number | R000012390 |
| Scientific Title | The association between heart rate variability and postoperative recovery of higher brain function in elderly patients |
| Date of disclosure of the study information | 2014/06/29 |
| Last modified on | 2022/12/01 15:18:59 |
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Basic information
Public title
The association between heart rate variability and postoperative recovery of higher brain function in elderly patients
Acronym
The association between heart rate variability and postoperative recovery of higher brain function in elderly patients
Scientific Title
The association between heart rate variability and postoperative recovery of higher brain function in elderly patients
Scientific Title:Acronym
The association between heart rate variability and postoperative recovery of higher brain function in elderly patients
Region
| Japan |
Condition
Condition
general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to delineate the association between preoperative HRV and postoperative memory impairment in elderly patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative memory impairment
heart rate variability
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
general anesthesia
Key exclusion criteria
auricular fibrillation
typical dementia
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Anesthesiology
Zip code
474-8511
Address
Morioka town Gengo 35
TEL
0562-46-2311
kmakoto@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Kobayashi |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Anesthesiology
Zip code
474-8511
Address
Morioka town 7tyome430
TEL
0562-46-2311
Homepage URL
kmakoto@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gerontology
Address
Morioka town 7-430 Ohbu, Aichi, 474-8511 JAPAN
Tel
0562-46-2311
kmakoto@ncgg.go.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
| 2014 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After obtaining institutional approval and written informed consent, patients over 70 yr of age undergoing surgery under general anesthesia are enrolled in this study. Memory function is assessed using Verbal Paired Associates (VPA) subtest from Wechsler Memory Scale-Revised (WMS-R) the day before surgery and first postoperative day. Heart Rate Variability was evaluated the day before surgery using MemCalc method. The power of low (0.04-0.15 Hz; LF) and high (0.15-0.4 Hz; HF) frequency component of Heart Rate Variability and the ratio of LF to HF (L/H) were calculated.
Management information
Registered date
| 2014 | Year | 05 | Month | 22 | Day |
Last modified on
| 2022 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012390
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
