UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019862
Receipt number 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 16:53:13

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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

Obstetrics 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

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

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 or person

Institute

Nihon University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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