UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045038 |
|---|---|
| Receipt number | R000051439 |
| Scientific Title | The response of vasopressors against hypotension during general anesthesia: a prospective observational study |
| Date of disclosure of the study information | 2021/08/02 |
| Last modified on | 2022/08/03 09:03:52 |
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Basic information
Public title
The response of vasopressors against hypotension during general anesthesia: a prospective observational study
Acronym
The response of vasopressors against hypotension during general anesthesia: a prospective observational study
Scientific Title
The response of vasopressors against hypotension during general anesthesia: a prospective observational study
Scientific Title:Acronym
The response of vasopressors against hypotension during general anesthesia: a prospective observational study
Region
| Japan |
Condition
Condition
General anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the cardiovascular effects of vasopressors change with age.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodynamic changes at 5 min after the administration of vasopressors
Key secondary outcomes
Hemodynamic changes at the other times
Bispectral index, rSO2
Response rate of vasopressors
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for general anesthesia and evaluated for anesthesia on ambulatory clinic in clinic
PS <= 2
age >= 45
Key exclusion criteria
PS >= 3
Heat disease history
Difficult to wear the monitor (e.g., it covers the surgical site)
Position change
Consent cannot be obtained
Total intravenous anesthesia
Others: Judged to be unsuitable for the study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
0886337181
michiko-kinoshita@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Kinoshita |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
7700-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
0886337181
Homepage URL
michiko-kinoshita@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Tokushima University Hospital
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
The Ethics Committee of Tokushima University Hospital
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
Tel
088-633-7181
michiko-kinoshita@tokushima-u.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
| 2021 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
75
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
| 2021 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation for age-related changes in hemodynamics when vasopressors are administered for hypotension during general anesthesia.
Observation of blood pressure, heart rate, esCCO, esSV, BIS, and rSO2.
Management information
Registered date
| 2021 | Year | 08 | Month | 02 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051439
