UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012390