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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034929
Receipt No. 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 2019/05/12

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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
Email 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
Email nabeko@dpc.agu.ac.jp

Sponsor
Institute Aichi Gakuin University School of Dentistry
Institute
Department

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
Email aya_i@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 Unpublished

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 Enrolling by invitation
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
2019 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039831

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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