UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021872
Receipt number R000025220
Scientific Title Effects of flurbiprofen on the hypotension following to thoracotomy.
Date of disclosure of the study information 2016/04/11
Last modified on 2017/03/30 14:29:35

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Basic information

Public title

Effects of flurbiprofen on the hypotension following to thoracotomy.

Acronym

Effects of flurbiprofen on the hypotension following to thoracotomy.

Scientific Title

Effects of flurbiprofen on the hypotension following to thoracotomy.

Scientific Title:Acronym

Effects of flurbiprofen on the hypotension following to thoracotomy.

Region

Japan


Condition

Condition

Elective lung resection cases

Classification by specialty

Chest surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

In the elective lung resection surgery, we study if flurbiprofen adiministration is abele to suppress the hypotension following to thoracotomy and re-expansion or not.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Intraoperative blood pressure

Key secondary outcomes

Intraoperative heart rate
Intraoperative dose of phenylephrine and ephedrine
Intraoperative infusion, transufusion, urine output, blood loss and fluid balance (ml/kg/h)
Postoperative dose of flurbiprofen.
Postoperative dose of phenylephrine.
Postoperative infusion, transufusion, urine output, blood loss and fluid balance (ml/kg/h).
Count of blood cells(WBC, RBC, hemoglobin, platelets) and biochemical tests (Alb, AST, ALP, LDH, BUN, Cr, CRP) on 1 and 7 postoperative day.
ICU stay days.
Hospital stay days.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Flurubiprofen administration on anesthesia induction

Interventions/Control_2

Flurbiprofen administration on wound closure

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Elective lung resection cases scheduled for left thoracotomy

Key exclusion criteria

History of flurbiprofen allergy
Active asthma
Chronic kidney disease

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hiroki Katoh

Organization

Hyogo Cancer Center

Division name

Department of Anesthesia

Zip code


Address

13-70 Kitaoji Akashi

TEL

0789291151

Email

whoami@hp.pref.hyogo.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromi Katoh

Organization

Hyogo Cancer Center

Division name

Department of Anesthesia

Zip code


Address

13-70 Kitaoji Akashi

TEL

0789291151

Homepage URL


Email

whoami@hp.pref.hyogo.jp


Sponsor or person

Institute

Hyogo Cancer Center
Department of Anesthesia

Institute

Department

Personal name



Funding Source

Organization

Hyogo Cancer Center
Department of Anesthesia

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

兵庫県立がんセンター


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 11 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://confit.atlas.jp/guide/event/jsa64/static/64th_program

Number of participants that the trial has enrolled


Results

In contrast to the significant hypotension in control group, flurbiprofen pretreatment maintained blood pressure after thoracotomy and
nondependent lung collapse. Dose of phenylephrine was significantly less in the flurbiprofen group for 10 to 60 minutes after thoracotomy. These results suggest that prostaglandin may correlate to the post thoracotomy hypotension.

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

2016 Year 03 Month 09 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 12 Day

Last follow-up date

2017 Year 03 Month 30 Day

Date of closure to data entry

2017 Year 03 Month 30 Day

Date trial data considered complete

2017 Year 03 Month 30 Day

Date analysis concluded

2017 Year 03 Month 30 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 11 Day

Last modified on

2017 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025220


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2017/03/30 FLU_集計.numbers