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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name