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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031828
Receipt No. R000035626
Scientific Title Changes in cerebral circulation by spinal anesthesia for caesarean section
Date of disclosure of the study information 2018/04/01
Last modified on 2020/03/22

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Basic information
Public title Changes in cerebral circulation by spinal anesthesia for caesarean section
Acronym Caesarean section and cerebral circulation
Scientific Title Changes in cerebral circulation by spinal anesthesia for caesarean section
Scientific Title:Acronym Caesarean section and cerebral circulation
Region
Japan

Condition
Condition Patients scheduled to have caesarean section
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the cerebral circulation such as cerebral oxygenation, cerebral blood volume and flow by spinal anesthesia for caesarean section. And to compare theses variables between the patients with and without nausea or dizziness.
Basic objectives2 Others
Basic objectives -Others search for the physiological changes
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Changes in cerebral circulation by spinal anesthesia foe caesarean section
Key secondary outcomes presence of nausea or dizziness

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

Not applicable
Gender Female
Key inclusion criteria ASA-PS1,2
Key exclusion criteria 1 Hypertension
2 DM
3 Renal dysfunction
4 cerebral disorder
5 BMI>30
6 treatment by ritodrine
Target sample size 28

Research contact person
Name of lead principal investigator
1st name Yuji
Middle name
Last name Morimoto
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code 0608648
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Email morim2@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Yuji
Middle name
Last name Morimoto
Organization Hokkaido University Hospital
Division name Anesthesiology
Zip code 0608648
Address N14 W5, Kita-ku, Sapporo
TEL 011-716-1161
Homepage URL
Email morim2@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Anesthesiology
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address N14 W5, Kita-ku, Sapporo
Tel 011-706-7061
Email crjimu@huhp.hokudai.ac.jp

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 北海道大学病院

Other administrative information
Date of disclosure of the study information
2018 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 28
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 No longer recruiting
Date of protocol fixation
2018 Year 03 Month 20 Day
Date of IRB
2018 Year 04 Month 09 Day
Anticipated trial start date
2018 Year 04 Month 16 Day
Last follow-up date
2020 Year 02 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study
observational items; Background, laboratory data, vital signs, cerebral oxygenation, cerebral blood flow velocity, nausea or dizziness during anesthesia

Management information
Registered date
2018 Year 03 Month 21 Day
Last modified on
2020 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035626

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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