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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019862
Receipt No. R000022942
Scientific Title Relationship between cerebral blood flow oxygenation changes and change in cardiac output and systemic vascular resistance after spinal anesthesia
Date of disclosure of the study information 2015/11/19
Last modified on 2017/06/06

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Basic information
Public title Relationship between cerebral blood flow oxygenation changes and change in cardiac output and systemic vascular resistance after spinal anesthesia
Acronym Relationship between maternal cerebral circulation change and hemodynamic change after spinal anesthesia for cesarean section
Scientific Title Relationship between cerebral blood flow oxygenation changes and change in cardiac output and systemic vascular resistance after spinal anesthesia
Scientific Title:Acronym Relationship between maternal cerebral circulation change and hemodynamic change after spinal anesthesia for cesarean section
Region
Japan

Condition
Condition Full term pregnancy women
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Correlation between change in maternal regional cerebral blood volume and oxygenation and change in cardiac output and systemic vascular resistance after spinal anesthesia for cesarean section
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between chnage in regional cerebral blood volume and oxygenation measured by near-infrared spectroscopy and change in cardiac output and systemic vascular resistance measured by arterial pressure based cardiac output monitaring system during 15 min after induction of spinal anesthesia
Key secondary outcomes 1. Characteristics of indexes of regional cerebral circulation and hemodynamic when appearence of adverse symptoms. 2. Change in indexes of regional cerebral circulation and hemodynamic after administration of vasopressor agents.

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
20 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Full-term pregnant women with placenta previa aged over 20, undergoing elective cesarean section under spinal anesthesia
Key exclusion criteria Patient with a diagnosis of hypertension, diabetes and renal dysfunction due to pregnancy, and obese patient whose BMI >30%.
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Noriya Hirose
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email hirose.noriya@nihon-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Noriya Hirose
Organization Nihon University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email hirose.noriya@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
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 日本大学医学部附属板橋病院(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 19 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
2014 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 10 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study (Case-control study)
Participants: Patients who will be received elective cesarean section under spinal anesthesia from August 2015 to March 2017.
Observation items: Change in maternal regional cerebral circulation and hemodynamic during spinal anesthesia.

Management information
Registered date
2015 Year 11 Month 19 Day
Last modified on
2017 Year 06 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022942

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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