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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027628
Receipt No. R000031656
Scientific Title Prospective evaluation of patient state index using different versions of Sedline
Date of disclosure of the study information 2017/06/05
Last modified on 2019/03/25

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Basic information
Public title Prospective evaluation of patient state index using different versions of Sedline
Acronym Patient state index in different versions of SedLine
Scientific Title Prospective evaluation of patient state index using different versions of Sedline
Scientific Title:Acronym Patient state index in different versions of SedLine
Region
Japan

Condition
Condition Unspecified diseases which require general anesthesia during surgery
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the difference in patient state index values between different versions of SedLine
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare the duration in which PSI values > 50 between different versions of SedLine when anesthesia is titrated so that BIS values around 50
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 During anesthesia, the older SedLine version is used
Interventions/Control_2 During anesthesia, the newer SedLine version is used
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
60 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients who are scheduled to undergo elective surgery which require general anesthesia and tracheal intubation and provided written informed consent whose physical status in American Society of Anesthesiologists classification I or II.
Key exclusion criteria Exclusion criteria includes known allergy to propofol; psychoneurotic disorders; psychiatric pharmacotherapy; chronic use of opioids; cirrhosis; and those who were considered inadequate.
Target sample size 36

Research contact person
Last name of lead principal investigator
1st name Murakawa
Middle name
Last name Masahiro
Organization Fukushima Medical University
Division name Anesthesiology
Zip code 9601295
Address 1 Hikarigaoka Fukushima City, Fukushima
TEL 0245471342
Email masui@fmu.ac.jp

Public contact
1st name of contact person
1st name Shinju
Middle name
Last name Obara
Organization Fukushima Medical University
Division name Surgical Operation Department
Zip code 9601295
Address 1 Hikarigaoka Fukushima City, Fukushima
TEL 0245471342
Homepage URL
Email masui@fmu.ac.jp

Sponsor
Institute Fukushima Medical University
Institute
Department

Funding Source
Organization Fukushima Medical University
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 Fukushima Medical University Research Ethics Committee
Address 1 Hikarigaoka, Fukushima City, Fukushima, JAPAN
Tel 0245471825
Email rs@fmu.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

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 05 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 36
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
2017 Year 06 Month 04 Day
Date of IRB
2017 Year 05 Month 30 Day
Anticipated trial start date
2017 Year 06 Month 05 Day
Last follow-up date
2019 Year 02 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 04 Day
Last modified on
2019 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031656

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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