UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012626
Receipt number R000014764
Scientific Title Studies to identify individual differences in anesthetic potency
Date of disclosure of the study information 2013/12/19
Last modified on 2019/12/24 17:33:18

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Basic information

Public title

Studies to identify individual differences in anesthetic potency

Acronym

Individual differences in anesthetic potency

Scientific Title

Studies to identify individual differences in anesthetic potency

Scientific Title:Acronym

Individual differences in anesthetic potency

Region

Japan


Condition

Condition

healthy subjects

Classification by specialty

Anesthesiology Adult

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

The effects of gender, aging and polymorphism on the individual differences in anesthetics(inhaled -, intravenous -, analgesics, etc)potency.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Individual differences in anesthetic effects.

Key secondary outcomes

Individual differences in side effects of anesthetics.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Anesthetics administration

Interventions/Control_2

Dose and time

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

Male and Female

Key inclusion criteria

Healthy male and female subjects (age range 20-70) in our Hospital.

Key exclusion criteria

Age >= 70 yr

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Inomata

Organization

University of Tsukuba

Division name

Department of Anesthesiology, Division of Clinical Medicine, Faculty of Medicine

Zip code


Address

Tsukuba City, Ibaraki 305-8575, Japan

TEL

029-853-3525

Email

inomatas@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shinichi Inomata

Organization

University of Tsukuba

Division name

Department of Anesthesiology, Division of Clinical Medicine, Faculty of Medicine

Zip code


Address

Tsukuba City, Ibaraki 305-8575, Japan

TEL

029-853-3525

Homepage URL


Email

inomatas@md.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba,

Organization

Division

Category of Funding Organization

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

筑波大学


Other administrative information

Date of disclosure of the study information

2013 Year 12 Month 19 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

Enrolling by invitation

Date of protocol fixation

2000 Year 04 Month 01 Day

Date of IRB

2002 Year 10 Month 03 Day

Anticipated trial start date

2002 Year 10 Month 03 Day

Last follow-up date

2030 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 12 Month 19 Day

Last modified on

2019 Year 12 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014764


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name