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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000014027
Receipt No. 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 2019/11/25

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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
Email 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
Email kmakoto@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
Email 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 Suspended
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
2019 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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