UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017942 |
|---|---|
| Receipt number | 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 17:40:15 |
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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
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
okay@po.mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020795
