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

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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name