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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018331
Receipt No. 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 2017/07/17

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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
Middle name
Last name manzo suzuki MD
Organization Musashikosugi hospital Nippon medical school
Division name Department of anesthesiology
Zip code
Address 1-369 kosugi nakaharaku kanagawa Japan
TEL 81-44-733-5181
Email manzo@nma.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Manzo Suzuki MD
Organization Musashikosugi hospital Nippon medical schoo
Division name Department of anesthesiology
Zip code
Address 1-369 kosugi nakaharaku kanagawa Japan
TEL 81-44-733-5181
Homepage URL
Email manzo@nms.ac.jp

Sponsor
Institute Department of anesthesiology, Musashikosugi Hospital Nippon Medical School
Institute
Department

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
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
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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
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
2017 Year 07 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021214

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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