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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012787
Receipt No. 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

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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
Email 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
Email ogawa.yojiro@nihon-u.ac.jp

Sponsor
Institute Division of Hygiene, Department of Social Medicine, Nihon University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014939

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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