UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Title of the study (Brief title)	The effect of ephedrine and etilefrine on perfusion index and pleth variability indicate
Region	Japan

Condition
Condition	surgical procedure under general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate prospectively changes in perfusion index and pleth variability by injection of ephedrine or etilefrine.
Basic objectives2	Others
Basic objectives -Others	To investigate prospectively changes in other hemodynamic values by injection
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in perfusion index and pleth variability indicate values
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	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Immediately before administering the drug, baseline values are recorded, and the values are recorded again for 5 minutes after ephedrine 10mg injection.
Interventions/Control_2	Immediately before administering the drug, baseline values are recorded, and the values are recorded again for 5 minutes after etilefrine 2mg injection.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with ASA physical status 1 or 2
Key exclusion criteria	1. Subjects who have an inappropriate clinical history for efficacy and safety assessment in the study (such as drug poisoning, alcoholism, and the disease of heart, liver, kidney, lungs, eye, blood, etc) and who is taking any drugs (including health supplements). 2. Any history for drug allergy. 3. Subjects who are inadequate for enrollment judged by the investigator.
Target sample size	80

Research contact person
Name of lead principal investigator	Zen'ichiro Wajima
Organization	Shioya hospital, International University of Health and Welfare
Division name	Department of Anesthesiology
Address	77 Tomita Yaita-shi, Tochigi, Japan
TEL	0287-44-1155
Email	zwajima@iuhw.ac.jp

Public contact
Name of contact person	Zen'ichiro Wajima
Organization	Shioya hospital, International University of Health and Welfare
Division name	Department of Anesthesiology
Address	77 Tomita Yaita-shi, Tochigi, Japan
TEL	0287-44-1155
Homepage URL
Email	zwajima@iuhw.ac.jp

Sponsor
Institute	Department of Anesthesiology, Shioya Hospital, International University of Health and Welfare
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	None
Organization
Division
Category of Funding Organization	Self funding
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	2014 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 15 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

Management information
Registered date	2014 Year 01 Month 15 Day
Last modified on	2016 Year 07 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015031