UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of warming on genral anesthetics requirement for loss of consciousness
Title of the study (Brief title)	Effect of warming on general anesthesia induction
Region	Japan

Condition
Condition	patient for general anesthesia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination on the effect of warming on general anesthestics requireent for loss of consciousness
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood concentration of general anethetics on loss of consciousness
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	Heated forced air at 43 degrees is delivered wihtin a full-body field using a warming unit
Interventions/Control_2	Putting on warming unit
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	patient with ASA physical classification of 1 or 2 who are scheduled surgery under general anesthesia
Key exclusion criteria	diabetic mellitus use of psychotropic agent
Target sample size	120

Research contact person
Name of lead principal investigator	Mikito Kawamata
Organization	Shinshu University school of medicine
Division name	the department of anesthesiology and resuscitology
Address	3-1-1 Asahi Matumoto city Nagano
TEL	0263-37-2670
Email	masui@shinshu-u.ac.jp

Public contact
Name of contact person	Norimasa Hishinuma
Organization	Shinshu University school of medicine
Division name	the department of anesthesiology and resuscitology
Address	3-1-1 Asahi Matumoto city Nagano
TEL	0263-37-2670
Homepage URL
Email	kojiromasakado@gmail.com

Sponsor
Institute	Shinshu University school of medicine
Institute
Department

Funding Source
Organization	Shinshu University school of medicine
Organization
Division
Category of Funding Organization
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 11 Month 29 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2014 Year 12 Month 01 Day
Anticipated trial start date	2014 Year 12 Month 01 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

Management information
Registered date	2014 Year 11 Month 28 Day
Last modified on	2019 Year 01 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018349