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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012777
Receipt No. R000014926
Scientific Title The effects of midazolam and flumazenil on cerebral circulation
Date of disclosure of the study information 2014/01/07
Last modified on 2014/01/08

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Basic information
Public title The effects of midazolam and flumazenil on cerebral circulation
Acronym Midazolam, flumazenil and cerebral circulation
Scientific Title The effects of midazolam and flumazenil on cerebral circulation
Scientific Title:Acronym Midazolam, flumazenil and cerebral circulation
Region
Japan

Condition
Condition healthy subjects
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effects of flumazenil administered after midazolam on cerebral circulation, to test our hypothesis that flumazenil antagonizes the alterations in cerebral circulation induced by midazolam.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cerebral blood flow velocity, arterial blood pressure, sedation depth, and cerebral circulation.
Key secondary outcomes Heart rate, respiratory condition, and autonomic circulatory regulation.

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Healthy male subjects receives midazolam followed by flumazenil.
Midazolam is administered at an initial bolus dose of 0.5 mg, and an additional bolus dose of 0.5 mg is administered every 2 min after OAA/S assessment until an OAA/S score of 3 (responds only after name is called loudly and/or repeatedly) is reached. Since an adequate sedative effect is maintained for at least 30 min after midazolam administration, flumazenil is administered at an initial bolus dose of 0.2 mg 30 min after final administration of midazolam, and additional bolus doses of 0.1 mg are administered every 2 min until an OAA/S score of 5 (responds readily to name spoken in a normal tone) 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
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 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
During midazolam sedation, BIS index, MAP, CBF velocity, and transfer function gain decreased significantly compared with baseline. After administration of flumazenil, BIS index and MAP returned to the same level as baseline. However, CBF velocity showed a further significant decrease compared with midazolam sedation, and the decreased transfer function gain persisted.
The present study suggest that despite complete antagonism of the sedative effects of midazolam, flumazenil dose not reverse the alterations in cerebral circulation induced by midazolam.
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
2010 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 06 Month 21 Day
Date trial data considered complete
2013 Year 06 Month 21 Day
Date analysis concluded
2013 Year 08 Month 30 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 07 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014926

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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