UMIN-CTR Clinical Trial

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