UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of induction anesthesia on the accuracy of non-invasive continuos hemoglobin measurement
Title of the study (Brief title)	Induction of anesthesia and the accuracy of non-invasive continuous hemoglobinmeasurement
Region	Japan

Condition
Condition	Patients who need an operation under fgeneral anesthesia
Classification by specialty	Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery Vascular surgery Chest surgery Endocrine surgery Breast surgery Obsterics and gynecology Ophthalmology Dermatology Oto-rhino-laryngology Orthopedics Urology Oral surgery Neurosurgery Cardiovascular surgery Plastic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Changes in perfusion index have a potential to affect the accuray of non-invasive hemoglobin measurement. Anesthesia can change in perfusion index. The purpose of this study is how induction of anesthesia affect on the accuracy of non-invasive hemoglobin measurement
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The difference between non-invasive continuous hemoglobin (SpHb) and hemoglobin before and after induction of anesthesia
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous infusion of phenylephrine (0.5mcg/kg/min) during induction of anesthesia
Interventions/Control_2	No drug infusion
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients aged >= 20 years to =< 80 years at informed consent 2. Patients who need an operation under general anesthesia 3. ASA 1 or 2
Key exclusion criteria	1. Past history of hypertension 2. Past history of intra cerebral hemorrhage 3. Past history of cerebral aneurysm and thoracic or abdominal aortic aneurysm 4. Past history of hypersensitivity for Phenylephrine
Target sample size	60

Research contact person
Name of lead principal investigator	Junichi Saito
Organization	Hirisaki University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	zaifu-cho 5, Hirosaki, Aomori, Japan
TEL	0172395113
Email	fix-you@hotmail.co.jp

Public contact
Name of contact person	Junichi Saito
Organization	Hirisaki University Graduate School of Medicine
Division name	Department of Anesthesiology
Address	5 zaifucho, Hirosaki
TEL	0172-33-5111
Homepage URL
Email	fix-you@hotmail.co.jp

Sponsor
Institute	Department of Anesthesiology, Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of Anesthesiology, Hirosaki University Graduate School of Medicine
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	2013 Year 07 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 11 Day
Anticipated trial start date	2013 Year 07 Month 20 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	Published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 07 Month 19 Day
Last modified on	2018 Year 11 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013160