UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Title of the study (Brief title)	Influence of anesthetics on cardiac dilatability of cardiovascular surgery patients
Region	Japan

Condition
Condition	Valvular heart disease Angina pectoris Myocardial infarction
Classification by specialty	Anesthesiology Cardiovascular surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Investigate the change in cardiac dilatability following introduction of anesthesia
Basic objectives2	Others
Basic objectives -Others	to be clinically applicable to the existence of changes in diastolic capacity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in cardiac dilatation ability before surgery due to use of anesthetic
Key secondary outcomes

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients undergoing cardiovascular operations
Key exclusion criteria	Patients whose preoperative cardiac echography did not measure E/e'.
Target sample size	400

Research contact person
Name of lead principal investigator	Yukio Hayashi
Organization	Sakurabashi Watanabe Hospital
Division name	Anesthesiology
Address	2-4-32 Umeda Kita-ku, Osaka-shi, Osaka
TEL	06-6341-0785
Email	yhayashi@anes.med.osaka-u.ac.jp

Public contact
Name of contact person	Tomoko Fujimoto
Organization	Sakurabashi Watanabe Hospital
Division name	Anesthesiology
Address	2-4-32 Umeda Kita-ku, Osaka-shi, Osaka
TEL	06-6341-0785
Homepage URL
Email	tomotomotomo0813@yahoo.co.jp

Sponsor
Institute	Sakurabashi Watanabe Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 11 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 01 Day
Anticipated trial start date	2018 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observational study

Management information
Registered date	2018 Year 12 Month 11 Day
Last modified on	2018 Year 12 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039790