UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033310 |
|---|---|
| Receipt number | R000035800 |
| Scientific Title | Changes in cerebral oxygenation by phenylephrine or ephedrine |
| Date of disclosure of the study information | 2018/07/06 |
| Last modified on | 2022/07/08 17:07:23 |
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Basic information
Public title
Changes in cerebral oxygenation by phenylephrine or ephedrine
Acronym
vasopressors and cerebral oxygenation
Scientific Title
Changes in cerebral oxygenation by phenylephrine or ephedrine
Scientific Title:Acronym
vasopressors and cerebral oxygenation
Region
| Japan |
Condition
Condition
Patients scheduled to have laparoscopic surgery
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the changes in cerebral oxygenation by phenylephrine or ephedrine under general anesthesia
Basic objectives2
Others
Basic objectives -Others
Search of the physiological changes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in cerebral oxygenation
Key secondary outcomes
Changes in cerebral hemoglobin concentration
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
Male and Female
Key inclusion criteria
1 Patients with ASA1 or 2
2 Patients with direct arterial blood pressure monitoring
Key exclusion criteria
1 Patients with cardiovascular disease
2 Patients with cerebral disorders
3 Patients with uncontrolled DM (HbA1c>7)
Target sample size
100
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
060-8648
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Kubo |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8638
Address
N14 W5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
hayatokirin@gmail.com
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
Clinical Research Administration
Address
N14 W5, Kita-ku, Sapporo
Tel
011-706-7636
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 06 | 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
23
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Data are not analyzed.
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 | 07 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Study period:until 2021.9.30
Adult patients scheduled to have laparoscopic surgery in the Hokkaido University Hospital
anticipated numbers
each 50 treatment in ephedrine or phenylephrine(total 100)
Observational items: Background, laboratory data, vital signs, cerebral hemoglobin concentration and oxygenation
Management information
Registered date
| 2018 | Year | 07 | Month | 06 | Day |
Last modified on
| 2022 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035800
