UMIN-CTR Clinical Trial

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
Email	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
Email	michiko-kinoshita@tokushima-u.ac.jp

Sponsor
Institute	Tokushima University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051439