UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Change of blood sugar level under the influence of anesthetics
Title of the study (Brief title)	Change of blood sugar level under the influence of anesthetics
Region	Japan

Condition
Condition	breast canser
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To examine a change of the blood sugar level after the sugar load by the difference of the anesthetic
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of blood sjgar or insulin level
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	60 years-old >=
Gender	Female
Key inclusion criteria	ASA-1 Woman Patient without complications and receive a breast cancer operation in our Hospital
Key exclusion criteria	There are complications An agreement is not provided
Target sample size	100

Research contact person
Name of lead principal investigator	Arisa Iwakura
Organization	Gifu University School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
Address	1-1 Yanagido Gihu-City
TEL	058-230-6404
Email	ars_i_0802@yahoo.co.jp

Public contact
Name of contact person	Iwakura Arisa
Organization	Gifu University School of Medicine
Division name	Department of Anesthesiology and Critical Care Medicine
Address	1-1 Yanagido Gihu-City
TEL	058-230-6404
Homepage URL
Email	ars_i_0802@yahoo.co.jp

Sponsor
Institute	Gifu University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Gifu University School of Medicine
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	2015 Year 05 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 23 Day
Anticipated trial start date	2014 Year 04 Month 10 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	Partially published
URL releasing results
Results
Other related information	Examine blood sugar level after having performed sugar load by general anesthesia, the change of the insulin level.

Management information
Registered date	2015 Year 05 Month 18 Day
Last modified on	2016 Year 05 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020239