UMIN-CTR Clinical Trial

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	40

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	Completed
Date of protocol fixation	2018 Year 12 Month 29 Day
Date of IRB	2018 Year 10 Month 02 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2023 Year 10 Month 01 Day
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	2021 Year 07 Month 30 Day

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