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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017942
Receipt No. R000020795
Scientific Title The optimal degree of nitrous oxide inhalation edation -The effects of nitrous oxide inhalation on sympathetic nervous response to pain stimulation-
Date of disclosure of the study information 2015/06/18
Last modified on 2019/05/16

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Basic information
Public title The optimal degree of nitrous
oxide inhalation edation
-The effects of nitrous oxide inhalation on sympathetic nervous response to pain stimulation-
Acronym Sleep/sedation and pressor response
Scientific Title The optimal degree of nitrous
oxide inhalation edation
-The effects of nitrous oxide inhalation on sympathetic nervous response to pain stimulation-
Scientific Title:Acronym Sleep/sedation and pressor response
Region
Japan

Condition
Condition Hypertension
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To test whether atenuated pressor responses to pain stimulation during sadation would be caused by suppressed sympathetic activation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes Muscle sympathetic nerve activity
Key secondary outcomes Blood pressure, Heart rate, Cardiac output, Stroke volume, Total peripheral resistance

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 30% nitrous oxide inhalation
40% nitrous oxide inhalation
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
25 years-old <=
Age-upper limit
41 years-old >
Gender Male
Key inclusion criteria Healthy adult men
Key exclusion criteria Overt history of chronic diseases (cardiopulmonary, neurological, renal diseases, renal artery stenosis, primary aldosteronism, and diabetes mellitus).
Inflammatory dental diseases
Sleep apnea
Smokers
BMI>32
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiyuki Okada
Organization Matsumoto Dental University
Division name Special Care Dnetistry
Zip code
Address 1780 Hirooka, Shiojiri, Nagano, Japan
TEL 0263-52-3100
Email okay@po.mdu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiyuki Okada
Organization Matsumoto Dental University
Division name Special Care Dnetistry
Zip code
Address 1780 Hirooka, Shiojiri, Nagano, Japan
TEL 0263-52-3100
Homepage URL
Email okay@po.mdu.ac.jp

Sponsor
Institute Matsumoto Dental University
Institute
Department

Funding Source
Organization Japan Society of the promotion of science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2015 Year 06 Month 18 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
2014 Year 04 Month 01 Day
Date of IRB
2015 Year 03 Month 31 Day
Anticipated trial start date
2015 Year 06 Month 30 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 06 Month 17 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020795

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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