UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040328
Receipt No. R000046016
Scientific Title Depth of anesthesia and electroencephalogram
Date of disclosure of the study information 2020/05/15
Last modified on 2020/05/08

* 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 Depth of anesthesia and electroencephalogram
Acronym Depth of anesthesia
Scientific Title Depth of anesthesia and electroencephalogram
Scientific Title:Acronym Depth of anesthesia and electroencephalogram
Region
Japan

Condition
Condition Fracture
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Relationships between depth of anesthesia and EEG
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes bispectral index
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Concentration of Anesthetics: 1 MAC
Interventions/Control_2 Concentration of Anesthetics: 1.5 MAC
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 Subjects undergoing orthopedic surgery for fracture
Key exclusion criteria psychiatry disease
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name oda
Organization Osaka City Juso Hospital
Division name anesthesiology
Zip code 532-0034
Address Nonaka-kita, Yodogawa-ku, Osaka
TEL 06-6150-8000
Email yutakaodayutaka@gmail.com

Public contact
Name of contact person
1st name Yutaka
Middle name
Last name Oda
Organization Osaka City Juso Hospital
Division name Anesthesioogy
Zip code 532
Address 2-12-17
TEL 0661508000
Homepage URL
Email yutakaodayutaka@gmail.com

Sponsor
Institute Osaka City Juso Hospital
Institute
Department

Funding Source
Organization Osaka City Juso Hospital
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 Osaka City Juso Hospital
Address Nonaka-kita, Yodogawa-ku, Osaka
Tel 0661508000
Email yutakaodayutaka@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
2020 Year 05 Month 15 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
2020 Year 04 Month 10 Day
Date of IRB
2020 Year 04 Month 30 Day
Anticipated trial start date
2020 Year 05 Month 20 Day
Last follow-up date
2023 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 08 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046016

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.