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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035777
Receipt No. R000039773
Scientific Title Study on the influence of cardiac output on blood concentration during continuous administration of fentanyl
Date of disclosure of the study information 2019/02/05
Last modified on 2019/02/05

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Basic information
Public title Study on the influence of cardiac output on blood concentration during continuous administration of fentanyl
Acronym Study on the influence of cardiac output on blood concentration during continuous administration of fentanyl
Scientific Title Study on the influence of cardiac output on blood concentration during continuous administration of fentanyl
Scientific Title:Acronym Study on the influence of cardiac output on blood concentration during continuous administration of fentanyl
Region
Japan

Condition
Condition Disease that is performed a free flap under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate correlation between the change of fentanyl blood concentration and change in cardiac output during fentanyl continuous infusion.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Correlation between the ratio or difference between blood concentration predicted by Shafer model and actual blood concentration of fentanyl and cardiac output or cardiac index
Key secondary outcomes Change of cardiac output using dopamine
Change of concentration of fentanyl and its metabolites
Measurement of activity of CYP3A (measurement of blood concentration of midazolam and metabolites)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.Patients who are over 20 years of age at consent acquisition
2.Patients with ASA-PS 1 to 3
3.After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria 1.Patient who did not obtain consent
2.Patients allergic to fentanyl
3.Patients with BMI> 30
4.Pregnant women / lactating women
5.Patients with liver failure / renal failure
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Baba
Organization Niigata University Graduate School of Medical and Dental Sciences
Division name Division of Anesthesiology
Zip code
Address 1-757 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL 025-223-2323
Email baba@med.niigata-u.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsunori Watanabe
Organization Niigata University Medical & Dental Hospital
Division name Department of Anesthesiology
Zip code
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8520, Japan
TEL 025-223-2328
Homepage URL
Email deepimpact034@yahoo.co.jp

Sponsor
Institute Niigata University Medical & Dental Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Department of Clinical Pharmacology, Gunma University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 05 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 Open public recruiting
Date of protocol fixation
2018 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2019 Year 02 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study the relationship between changes in circulatory dynamics and fentanyl concentration during continuous fentanyl administration

Management information
Registered date
2019 Year 02 Month 05 Day
Last modified on
2019 Year 02 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039773

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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