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
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
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
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
