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
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
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
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
