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
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	Not applicable

Assessment
Primary outcomes	Individual differences in anesthetic dose or concentration.
Key secondary outcomes	Individual differences in side effects of anesthetics.

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	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	200

Research contact person
Name of lead principal investigator	1st name Shinichi Middle name Last name Inomata
Organization	University of Tsukuba
Division name	Department of Anesthesiology, Division of Clinical Medicine, Faculty of Medicine
Zip code	3058575
Address	Tennoudai 1-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL	029-853-3525
Email	inomatas9981@yahoo.co.jp

Public contact
Name of contact person	1st name Shinichi Middle name Last name Inomata
Organization	University of Tsukuba
Division name	Department of Anesthesiology, Division of Clinical Medicine, Faculty of Medicine
Zip code	305-8576
Address	Tennnoudai 1-1-1, Tsukuba City, Ibaraki 305-8575, Japan
TEL	029-853-3525
Homepage URL
Email	inomatas9981@yahoo.co.jp

Sponsor
Institute	University of Tsukuba, Department of Anesthesiology
Institute
Department

Funding Source
Organization	Japanese Governmental Office
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	T-CReDO
Address	Amakubo 2-1-1, Tsukuba City, Ibaraki 305-8576, Japan
Tel	029-853-7562
Email	rinshokenkyu@un.tsukuba.ac.jp

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	筑波大学附属病院

Other administrative information
Date of disclosure of the study information	2022 Year 11 Month 21 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	Preinitiation
Date of protocol fixation	2022 Year 11 Month 15 Day
Date of IRB	2022 Year 12 Month 15 Day
Anticipated trial start date	2022 Year 12 Month 15 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2022 Year 11 Month 15 Day
Last modified on	2022 Year 11 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056379