UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018331 |
|---|---|
| Receipt number | R000021214 |
| Scientific Title | Effect of remifentanil based anesthesia on perioperative phagocytic function. |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2020/06/08 15:37:33 |
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Basic information
Public title
Effect of remifentanil based anesthesia on perioperative phagocytic function.
Acronym
remifentanil and neutrophil
Scientific Title
Effect of remifentanil based anesthesia on perioperative phagocytic function.
Scientific Title:Acronym
remifentanil and neutrophil
Region
| Japan |
Condition
Condition
patients who receives remifentanil or fentanyl based anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clear whether the neutrophils in the patients who received remifentanil based anesthesia develop the depression of phagocytosis and oxidative burst.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
pahgocytic function and respiratory burst of neitrophil who received remifentanil aor fentanyl based anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
fentayl will be used for analgesic other than remifentanil
Interventions/Control_2
patients who receives remifentanil
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
surgery which undergo clean surgical field
such as superficial surgery
Key exclusion criteria
patients who received chemotherapy, patients who with febrile symptom.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | manzo |
| Middle name | |
| Last name | suzuki |
Organization
Musashikosugi hospital Nippon medical school
Division name
Department of anesthesiology
Zip code
211-8533
Address
1-369 kosugi nakaharaku kanagawa Japan
TEL
81-44-733-5181
manzo@nma.ac.jp
Public contact
Name of contact person
| 1st name | Manzo |
| Middle name | |
| Last name | Suzuki |
Organization
Musashikosugi hospital Nippon medical schoo
Division name
Department of anesthesiology
Zip code
211-8533
Address
1-369 kosugi nakaharaku kanagawa Japan
TEL
81-44-733-5181
Homepage URL
manzo@nms.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Musashikosugi Hospital Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology, Musashikosugi Hospital Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB committee Musashikosugi hospital nippon Medical school
Address
1-396 kosugi-cho nakaharaku kawasaki japan
Tel
044-733-5181
tajima@nms.ac.jp
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
| 2017 | Year | 01 | Month | 01 | 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
| 2015 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 16 | Day |
Last modified on
| 2020 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021214
