UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034929 |
|---|---|
| Receipt number | R000039831 |
| Scientific Title | The usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam |
| Date of disclosure of the study information | 2018/11/20 |
| Last modified on | 2022/04/24 01:21:12 |
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Basic information
Public title
The usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam
Acronym
The usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam
Scientific Title
The usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam
Scientific Title:Acronym
The usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Anesthesiology | Oral surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the usefulness of infusion of fentanyl for intravenous sedation of dexmedetomidine and midazolam
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
respiratory and circulatory rate
Key secondary outcomes
1)amnesic effect
2)analgesic effect
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention of this study is to use dexmedetomidine and midazolam for intravenous sedation.
Interventions/Control_2
Intervention of this study is to use dexmedetomidine, midazolam and infusion of fentanyl for intravenous sedation.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy Adults
Key exclusion criteria
The exclusion criteria is as follows.
Patients who have untreated respiratory or/and circuratory disease preoperatively
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Okuda |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
464-8651
Address
2-11 Suemori-dori, Chikusa-ku, Nagoya, Aichi, Japan
TEL
052-759-2102
okudamacbookpro@gmail.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Okumura |
Organization
Aichi Gakuin University School of Dentistry
Division name
Department of Anesthesiology
Zip code
464-8651
Address
2-11 Suemori-dori,Chikusa-ku,Nagoya,Aichi, Japan
TEL
052-759-2102
Homepage URL
nabeko@dpc.agu.ac.jp
Sponsor or person
Institute
Aichi Gakuin University School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Aichi Gakuin University School of Dentistry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Gakuin University Ethics Committee
Address
2-11 Suemori-dori,Chikusa-ku,Nagoya,Aichi,464-8651,Japan
Tel
052-751-2561
hibi01@dpc.agu.ac.jp
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
愛知学院大学歯学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 20 | 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
50
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
| 2018 | Year | 11 | Month | 19 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 19 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039831
| 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 |
