UMIN-CTR Clinical Trial

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
Institute	University of Tsukuba
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014764