UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012777 |
|---|---|
| Receipt number | 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 12:23:03 |
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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
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
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 | 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014926
