UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015776
Receipt number R000018349
Scientific Title Effect of warming on genral anesthetics requirement for loss of consciousness
Date of disclosure of the study information 2014/11/29
Last modified on 2019/01/21 11:57:28

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Basic information

Public title

Effect of warming on genral anesthetics requirement for loss of consciousness

Acronym

Effect of warming on general anesthesia induction

Scientific Title

Effect of warming on genral anesthetics requirement for loss of consciousness

Scientific Title:Acronym

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

1st name
Middle name
Last name Mikito Kawamata

Organization

Shinshu University school of medicine

Division name

the department of anesthesiology and resuscitology

Zip code


Address

3-1-1 Asahi Matumoto city Nagano

TEL

0263-37-2670

Email

masui@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Norimasa Hishinuma

Organization

Shinshu University school of medicine

Division name

the department of anesthesiology and resuscitology

Zip code


Address

3-1-1 Asahi Matumoto city Nagano

TEL

0263-37-2670

Homepage URL


Email

kojiromasakado@gmail.com


Sponsor or person

Institute

Shinshu University school of medicine

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

No longer recruiting

Date of protocol fixation

2014 Year 12 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018349


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name