UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004606
Receipt number R000005500
Scientific Title How to assess the individual sensitivity to intravenous anesthetic
Date of disclosure of the study information 2010/11/23
Last modified on 2016/12/29 15:55:28

* 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

How to assess the individual sensitivity to intravenous anesthetic

Acronym

How to assess the individual sensitivity to intravenous anesthetic

Scientific Title

How to assess the individual sensitivity to intravenous anesthetic

Scientific Title:Acronym

How to assess the individual sensitivity to intravenous anesthetic

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

As sensitivity to intravenous anesthetic is widely varied among patients, EEG monitor is used. The purpose of this study is to fine the method to assess the sensitivity to intravenous anesthetic without using EEG monitor by investigating the relationship between estimated effect-site concentration (Ce) of anesthetic at loss of response to verbal command and Ce at some status assessed by EEG monitor. We also explore new evaluating method of anesthetic effect on EEG.

Basic objectives2

PK,PD

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To obtain the relationship between the effect-site concentration and that required for maintenance of anesthesia.

Key secondary outcomes

To find a new method to evaluate the effect of anesthetic by investigating the concentration related changes of EEG.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Female

Key inclusion criteria

Patients of ASA-PS I or II, who are scheduled mammectomy for their breast cancer

Key exclusion criteria

patients who has a disease in central nervous system. patients who are using the drugs that may influence the EEG, such as psychomimetic drugs

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Hagihira

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code


Address

2-2 Yamadaoka, Suita City, Osaka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Satoshi Hagihira

Organization

Osaka University Graduate School of Medicine

Division name

Department of Anesthesiology and Intensive Care Medicine

Zip code


Address

2-2 Yamadaoka, Suita City, Osaka

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Departmential sources

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

大阪大学医学部附属病院(大阪府)


Other administrative information

Date of disclosure of the study information

2010 Year 11 Month 23 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

2009 Year 02 Month 18 Day

Date of IRB


Anticipated trial start date

2009 Year 07 Month 01 Day

Last follow-up date


Date of closure to data entry

2010 Year 10 Month 31 Day

Date trial data considered complete

2010 Year 10 Month 31 Day

Date analysis concluded



Other

Other related information

Three effect-site concentrations in each patient are recorded; at loss of response, maintenance of anesthesia, recovery of response.


Management information

Registered date

2010 Year 11 Month 23 Day

Last modified on

2016 Year 12 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005500


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name