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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021462
Receipt No. R000024736
Scientific Title Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Date of disclosure of the study information 2016/04/01
Last modified on 2020/05/27

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Basic information
Public title Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Acronym Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Scientific Title Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Scientific Title:Acronym Usefulness of preoperative Metabolic equivalents for Geriatric patients performed Spinal Anesthesia
Region
Japan

Condition
Condition trochanteric fracture
Classification by specialty
Orthopedics Anesthesiology Operative medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate whether Metabolic equivalents is useful as preoperative evaluation for geriatric patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Duration of intraoperative hypotension
Myocardial markers
Key secondary outcomes Total dose of vasopressors
Hepatic markers
Renal markers
30 and 90 days mortality

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
100 years-old >
Gender Male and Female
Key inclusion criteria the patients with trochanteric fracture who are performed spinal anesthesia
Key exclusion criteria who cannot be performed spinal anesthesia
who cannot be evaluated by Metabolic equivalents because of dementia, respiratory dysfunction, lumbar diseases and joint diseases and so on
operative duration is longer than 2 hours
operative breeding is more than 1000ml
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Sakai
Organization Takikawa General City Hospital
Division name Anesthesiology
Zip code
Address 34gou, 2ban, 2chome, Omachi, Takikawa City, Hokkaido, Japan
TEL 0125-22-4311
Email sakaiwataru1128@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Wataru Sakai
Organization Takikawa General City Hospital
Division name Anesthesiology
Zip code
Address 34gou, 2ban, 2chome, Omachi, Takikawa City, Hokkaido, Japan
TEL 0125-22-4311
Homepage URL
Email sakaiwataru1128@gmail.com

Sponsor
Institute Department of Anesthesiology, Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization Takikawa General City Hospital
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 04 Month 01 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 Completed
Date of protocol fixation
2015 Year 04 Month 01 Day
Date of IRB
2015 Year 03 Month 10 Day
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information this study is started at 1/4/2016.
the patients with trochanteric fracture who are performed spinal anesthesia

Management information
Registered date
2016 Year 03 Month 13 Day
Last modified on
2020 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024736

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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