UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Relationship between cerebral blood flow oxygenation changes and change in cardiac output and systemic vascular resistance after spinal anesthesia
Title of the study (Brief title)	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
Name of lead principal investigator	Noriya Hirose
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
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	Noriya Hirose
Organization	Nihon University School of Medicine
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022942