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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035402
Receipt No. R000040316
Scientific Title The effect of H1 receptor antagonist, hydroxyzine on electroencephalogram of patients under general anesthesia
Date of disclosure of the study information 2018/12/29
Last modified on 2018/12/29

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Basic information
Public title The effect of H1 receptor antagonist, hydroxyzine on electroencephalogram of patients under general anesthesia
Acronym The effect of H1 receptor antagonist, hydroxyzine on electroencephalogram of patients under general anesthesia
Scientific Title The effect of H1 receptor antagonist, hydroxyzine on electroencephalogram of patients under general anesthesia
Scientific Title:Acronym The effect of H1 receptor antagonist, hydroxyzine on electroencephalogram of patients under general anesthesia
Region
Japan

Condition
Condition Patients undergoing elective surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify the role of histamine neurons on general anesthesia by analyzing electroencephalogram of patients under general anesthesia before and after administering H1 receptor antagonist, hydroxyzine.
Basic objectives2 Others
Basic objectives -Others Physiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of electroencephalographic bicoherence after administering hydroxyzine
Key secondary outcomes Changes of electroencephalographic power and bispectral index after administering hydroxyzine

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
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients undergoing elective surgery under general anesthesia
Key exclusion criteria Patients with neurological or psychiatric disease
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryusuke Tanaka
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Email rtanaka@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryusuke Tanaka
Organization Shinshu University School of Medicine
Division name Department of Anesthesiology and Resuscitology
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2670
Homepage URL
Email rtanaka@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Shinshu University School of Medicine Department of Anesthesiology and Resuscitology
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
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 4177
Org. issuing International ID_1 Institutional Review Board of Shinshu University School of Medicine
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 29 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
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 Preinitiation
Date of protocol fixation
2018 Year 12 Month 29 Day
Date of IRB
Anticipated trial start date
2019 Year 01 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 nothing

Management information
Registered date
2018 Year 12 Month 29 Day
Last modified on
2018 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040316

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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