UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019609
Receipt number R000022662
Scientific Title The effect on cytokine under use high-dose remifentanil in laparoscopic rectal - colon surgery
Date of disclosure of the study information 2015/11/05
Last modified on 2015/11/21 08:32:37

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Basic information

Public title

The effect on cytokine under use high-dose remifentanil in laparoscopic rectal - colon surgery

Acronym

The effect on cytokine under use high-dose remifentanil in laparoscopic rectal - colon surgery

Scientific Title

The effect on cytokine under use high-dose remifentanil in laparoscopic rectal - colon surgery

Scientific Title:Acronym

The effect on cytokine under use high-dose remifentanil in laparoscopic rectal - colon surgery

Region

Japan


Condition

Condition

colon-rectal cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of remifentanil to stress hormones and cytokines when used at high doses in laparoscopic colorectal surgery

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Cortisol and TNF-alpha and IL-6 concentration in the blood before start and after anesthesia and after the surgery
vital sign durig the surgery

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Administration concentration is the High-dose group is 1gamma

Interventions/Control_2

Administration concentration is the control group 0.25gamma

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients in adults , in the cooperative patient to understand the significance of taking part in a clinical intervention study of ASA PS 1 or 2

Key exclusion criteria

Patients with diabetes , autoimmune diseases , taking oral steroid

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsukasa Kochiyama

Organization

Juntendo university urayasu hospital

Division name

Anesthesiology

Zip code


Address

Chiba_Urayasu_city_Tomioka 2_1_1

TEL

047-353-3111

Email

tsukasa.coach.1109@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Tsuasa Kochiyama

Organization

Juntendo university urayasu hospital

Division name

Anesthesiology

Zip code


Address

Chiba_Urayasu_city_Tomioka 2_1_1

TEL

047-353-3111

Homepage URL


Email

tsukasa.coach.1109@gmail.com


Sponsor or person

Institute

Juntendo university of urayasu hospital
department of Anesthesiology

Institute

Department

Personal name



Funding Source

Organization

Juntendo university urayasu hospital department of Anesthesiology

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

順天堂大学医学部附属浦安病院(千葉県)


Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 05 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

2011 Year 10 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2015 Year 11 Month 30 Day

Date of closure to data entry

2016 Year 05 Month 31 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 11 Month 02 Day

Last modified on

2015 Year 11 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name