UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049321 |
|---|---|
| Receipt number | R000056167 |
| Scientific Title | Investigation of optimal parameters for ideal perioperative management |
| Date of disclosure of the study information | 2022/10/26 |
| Last modified on | 2022/10/26 00:16:48 |
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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
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
iwakirim-ane@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056167
