UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035402 |
|---|---|
| Receipt number | 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 | 2021/07/30 10:25:39 |
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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
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
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
rtanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040316
