UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the relationship between food allergy and anesthetics
Acronym	Investigation of the relationship between food allergy and anesthetics
Scientific Title	Investigation of optimal parameters for ideal perioperative management
Scientific Title:Acronym	Investigation of optimal parameters for ideal perioperative management
Region	Japan

Condition
Condition	Food allergy
Classification by specialty	Clinical immunology Surgery in general Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether propofol increases the risk of allergic reactions in patients with food allergies.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	a relative risk of allergic reactions after propofol use for patients with egg/soybean allergy.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Adult patients who underwent surgery involving anesthesiologists from 1 January 2018 to 31 December 2021.
Key exclusion criteria	Electroconvulsive therapy
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Kanji Middle name Last name Uchida
Organization	The University of Tokyo Hospital.
Division name	Department of Anesthesiology and Pain Relief Center
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81338155411
Email	uchidak-ane@h.u-tokyo.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Iwakiri
Organization	The University of Tokyo Hospital.
Division name	Department of Anesthesiology and Pain Relief Center
Zip code	113-8655
Address	7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL	+81338155411
Homepage URL
Email	iwakirim-ane@h.u-tokyo.ac.jp

Sponsor
Institute	The University of Tokyo.
Institute
Department

Funding Source
Organization	self
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	Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033 JAPAN
Tel	+813-5841-0818
Email	ethics@m.u-tokyo.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	2022 Year 10 Month 26 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	22111
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	2022 Year 04 Month 01 Day
Date of IRB	2018 Year 11 Month 12 Day
Anticipated trial start date	2022 Year 05 Month 01 Day
Last follow-up date	2022 Year 05 Month 01 Day
Date of closure to data entry	2022 Year 05 Month 01 Day
Date trial data considered complete	2022 Year 05 Month 01 Day
Date analysis concluded	2022 Year 06 Month 01 Day

Other
Other related information	Allergic reactions within 24 hours after propofol administration

Management information
Registered date	2022 Year 10 Month 26 Day
Last modified on	2022 Year 10 Month 26 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056167