UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Caridiovascular reflex responses to temporal reduction in arterial pressure during and after intravenous sedation
Title of the study (Brief title)	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	Ken-ichi Iwasaki / Yojiro Ogawa
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
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	Yojiro Ogawa
Organization	Nihon University School of Medicine
Division name	Division of Hygiene, Department of Social Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014939