UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019005
Receipt number R000021982
Scientific Title The Study of Allergic Reactions During Anesthesia Induction
Date of disclosure of the study information 2015/09/15
Last modified on 2019/03/18 18:03:17

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Basic information

Public title

The Study of Allergic Reactions During Anesthesia Induction

Acronym

The Study of Allergic Reactions During Anesthesia Induction

Scientific Title

The Study of Allergic Reactions During Anesthesia Induction

Scientific Title:Acronym

The Study of Allergic Reactions During Anesthesia Induction

Region

Japan


Condition

Condition

Patients undergoing elective surgery

Classification by specialty

Surgery in general Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is examining the association between the frequency of allergic reaction and hypotension during anesthesia induction

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We'll evaluate serum tryptase and histamine levels after anesthesia induction

Key secondary outcomes



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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

Acquisition of informed consent
The patients who has to insert an arterial pressure line under local anesthesia (before anesthesia induction)

Key exclusion criteria

Anemia (Hb<8g/dL)
Emergency surgery
ASAPS>=4

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Sumio
Middle name
Last name Hoka

Organization

Kyushu University

Division name

Department of Anesthesiology and Critical Care Medicine

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

+81926425714

Email

shoka@kuaccm.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Ryohei
Middle name
Last name Miyazaki

Organization

Kyushu University Hospital

Division name

Operating Rooms

Zip code

8128582

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

TEL

+81926425714

Homepage URL


Email

miyaryou@kuaccm.med.kyushu-u.ac.jp


Sponsor or person

Institute

Department of Anesthesiology and Critical Care Medicine, Kyushu University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu University IRB

Address

3-1-1, Maidashi, Higashi-ku, Fukuoka

Tel

+816425714

Email

ijkseimei@jimu.kyushu-u.ac.jp


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 09 Month 15 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

Completed

Date of protocol fixation

2014 Year 01 Month 01 Day

Date of IRB

2013 Year 12 Month 15 Day

Anticipated trial start date

2014 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information

Research perticipants: All patients who underwent cardiac surgery and met the selection criteria at Kyushu University Hospital from January 2014.

The prospective observational study of the association between allergic reactions and hypotension during anesthesia induction


Management information

Registered date

2015 Year 09 Month 14 Day

Last modified on

2019 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021982