UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031828 |
|---|---|
| Receipt number | 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 | 2020/08/22 14:56:59 |
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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
| Obstetrics 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
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
morim2@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology
Institute
Department
Personal name
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
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
Completed
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
| 2020 | Year | 08 | Month | 08 | Day |
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 | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035626
