UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035777 |
|---|---|
| Receipt number | 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 | 2022/12/20 00:22:22 |
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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
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
deepimpact034@yahoo.co.jp
Sponsor or person
Institute
Niigata University Medical & Dental Hospital
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 05 | Day |
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
| 2022 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039773
