臨床研究等提出・公開システム

Date of registration	Nov. 22, 2021
Last modified on	Nov. 22, 2021
Trial ID	jRCT1030210439

Scientific Title	Examination of histamine/tryptase threshold for the diagnosis of perioperative anaphylaxis
Public Title	Examination of histamine/tryptase threshold for the diagnosis of perioperative anaphylaxis

Contact for Scientific Queries	Name	Takazawa Tomonori
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan
	Telephone	+81-27-220-7111
	E-mail	takazawt@gunma-u.ac.jp
Contact for Public Queries	Name	Takazawa Tomonori
	Affiliation	Gunma University Hospital
	Address	3-39-15 Showa-machi, Maebashi , Gunma, Japan
	Telephone	+81-27-220-7111
	E-mail	takazawt@gunma-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Nov. 22, 2021
Target sample size		30
Study Type		Observational
Key inclusion & exclusion criteria	Inclusion Criteria	1) A volunteer who is 20 years or older 2) A volunteer who is undergoing general anesthesia 3) A volunteer whose blood pressure is monitored with an arterial line during anesthesia 4) A volunteer whose written consent has been obtained regarding participation in this study
	Exclusion Criteria	1) A volunteer who is suffered from perioperative anaphylaxis 2) A volunteer taking antihistamines 3) A volunteer taking steroids 4) A volunteer to whom a doctor judged inappropriate for participating in this study
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Anaphylaxis
Health Condition(s) Keyword		Anaphylaxis
Health Condition(s) Code		D000707
Primary Outcome(s)		Seeking the optimum value of histamine for diagnosing perioperative anaphylaxis.
Secondary Outcome(s)		Seeking the optimum value of tryptase for diagnosing perioperative anaphylaxis.

Primary Sponsor	Gunma University Hospital

Source of Monetary Support / Secondary Sponsor	Gunma University Hospital
Secondary Sponsor	Not applicable

Source of Monetary Support	KAKENHI, Japan Society for the Promotion of Science (JSPS)
Secondary Sponsor	Not applicable

Name of Certified Review Board	Gunma University Hospital Clinical Research Review Board
Address	3-39-15, Showa-machi, Maebashi, Gunma
Telephone	+81-27-220-8740
E-Mail	irb-jimukk-ciru@ml.gunma-u.ac.jp
Approval Status	Approval
Date of approval	Oct. 29, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none