UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017923 |
|---|---|
| Receipt number | R000020773 |
| Scientific Title | Heart rate variability in patients during anestheisa |
| Date of disclosure of the study information | 2015/07/06 |
| Last modified on | 2017/09/05 10:45:50 |
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Basic information
Public title
Heart rate variability in patients during anestheisa
Acronym
HRV
Scientific Title
Heart rate variability in patients during anestheisa
Scientific Title:Acronym
HRV
Region
| Japan |
Condition
Condition
Patients who undergo surgery
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate heart rate variability affected by complication, procedure and anesthetic agents.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
results from Heart rate variability
Key secondary outcomes
relationship between the heart rate variability and monitoring with BIS, pupils and respiration.
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
| 6 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients whoundergo surgery
Key exclusion criteria
none
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anesthesiology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
ane052@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Nakahira |
Organization
Osaka Medical College
Division name
Department of Anestheisology
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL
072-683-1221
Homepage URL
ane052@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪医科大学付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 06 | 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
Our computer for analysis of heart rate variability has not been working. There were no data with us.
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
| 2015 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 22 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 22 | Day |
Date trial data considered complete
| 2017 | Year | 06 | Month | 22 | Day |
Date analysis concluded
| 2017 | Year | 06 | Month | 22 | Day |
Other
Other related information
This is a prospective observational study which investigates heart rate variability in patients who undergo surgery with genara and/or local anesthesia. We detect the difference of heart rate viriability in the patients ibetween the preoperative complications, procedure and anestheic agents.
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2017 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020773
| Research Plan | |
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| 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 |
