UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021231
Receipt number R000024492
Scientific Title A search for optimal anesthetic agents for patients with cancer
Date of disclosure of the study information 2016/02/28
Last modified on 2023/03/04 12:55:16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

A search for optimal anesthetic agents for patients with cancer

Acronym

cancer resection and anesthetic agents

Scientific Title

A search for optimal anesthetic agents for patients with cancer

Scientific Title:Acronym

cancer resection and anesthetic agents

Region

Japan


Condition

Condition

cancer

Classification by specialty

Surgery in general Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of anesthetic agents on the cytotoxicity of natural killer cells in patients undergoing cancer resection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The cytotoxic activity of natural killer cells

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

general anesthesia using propofol and remifentanil for cancer resection

Interventions/Control_2

general anesthesia using propofol, remifentanil and ketamne for cancer resection

Interventions/Control_3

general anesthesia using sevoflurane and remifentanil for cancer resection

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

18 years-old <

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Cancer patients with written informed consent who can understand the aim of the study

Key exclusion criteria

Cancer patients who decline the consent of the study

Target sample size

80


Research contact person

Name of lead principal investigator

1st name Hidetomo
Middle name
Last name Niwa

Organization

Hirosaki university hopspital

Division name

Division of Intensive Care Unit

Zip code

036-8563

Address

Hirosaki Hontyo-3, Aomori, Japan

TEL

0172-39-5022

Email

niwahide@gmail.com


Public contact

Name of contact person

1st name Hidetomo
Middle name
Last name Niwa

Organization

Hirosaki university hopspital

Division name

Division of Intensive Care Unit

Zip code

036-8563

Address

Hirosaki Hontyo-53, Aomori, Japan

TEL

0172-39-5022

Homepage URL


Email

niwahide@gmail.com


Sponsor or person

Institute

Hirosaki university hopspital

Institute

Department

Personal name



Funding Source

Organization

Department of anesthesiology, Hirosaki university hospital

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Hirosaki university hosipital

Address

Hirosaki Honcho 53, Aomori

Tel

0172-33-5113

Email

niwahide@gmail.com


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

2016 Year 02 Month 28 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

2016 Year 03 Month 01 Day

Date of IRB

2016 Year 01 Month 19 Day

Anticipated trial start date

2016 Year 04 Month 01 Day

Last follow-up date

2025 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 02 Month 27 Day

Last modified on

2023 Year 03 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024492


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name