UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012787 |
|---|---|
| Receipt number | R000014939 |
| Scientific Title | Caridiovascular reflex responses to temporal reduction in arterial pressure during and after intravenous sedation |
| Date of disclosure of the study information | 2014/01/08 |
| Last modified on | 2018/01/12 12:18:33 |
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Basic information
Public title
Caridiovascular reflex responses to temporal reduction in arterial pressure during and after intravenous sedation
Acronym
Intravenous sedation and circulatory regualation
Scientific Title
Caridiovascular reflex responses to temporal reduction in arterial pressure during and after intravenous sedation
Scientific Title:Acronym
Intravenous sedation and circulatory regualation
Region
| Japan |
Condition
Condition
Healthy male volunteers
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study was designed to determine circulatory regulation during midazolam or propofol sedation and to characterize their recovery recovery profile.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Arterial blood pressure, heart rate, stroe volume, autonomic circulatory regulation, and sedation depth.
Key secondary outcomes
cerebral circulation, and respiratory condition.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Midazolam is administered at an initial bolus dose of 0.5 mg, and the additional bolus dose of 0.5 mg is administrated every 2 min after OAA/S assessment until OAA/S 3 (responds only after name is called loudly and/or repeatedly) is reached.
At a minimum of 7 days after midazolam protocol, propofol is infused at an initial dose of 2.0 mg/kg/h for 5 min and increased in increments of 0.5 mg/kg/h every 5 min after OAA/S assessment until OAA/S 3 (responds only after name is called loudly and/or repeatedly) is reached.
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
Key inclusion criteria
Healthy male consented to participate in this study.
Key exclusion criteria
1) Not satisfy selection criteria noted above.
2) Volunteers having allergic factors to foods and/or drugs.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken-ichi Iwasaki / Yojiro Ogawa |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
iwasaki.kenichi@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yojiro Ogawa |
Organization
Nihon University School of Medicine
Division name
Division of Hygiene, Department of Social Medicine
Zip code
Address
30-1, Oyaguchi-Kamimachi, Itabashi-ku, Tokyo
TEL
03-3972-8111
Homepage URL
ogawa.yojiro@nihon-u.ac.jp
Sponsor or person
Institute
Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Non profit foundation
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
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学医学部（Nihon University School of Medicine）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In several subjects, experimental data during midazolam sedation were measured.
Moreover, experimental data during propofol sedation were measured in a few subjects.
Management information
Registered date
| 2014 | Year | 01 | Month | 08 | Day |
Last modified on
| 2018 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014939
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
