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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029983
Receipt No. R000034242
Scientific Title Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia
Date of disclosure of the study information 2017/11/20
Last modified on 2018/06/28

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Basic information
Public title Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia
Acronym BIS and PSI
Scientific Title Relibility of BIS (BIS monitor) and PSI (SEDLine system) during desflurane anesthesia
Scientific Title:Acronym BIS and PSI
Region
Japan

Condition
Condition Patients under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 BIS in BIS monitor and PSI in SEDLine system are widely used for the evaluation of depth of general anesthesia. Unfortunately, both analytic software using either BIS monitor or SEDLine system is based on the data of propofol anesthesia and sevoflurane anesthesia and the data of desflurane anesthesia is not used. Validity of analytic software using either BIS monitor or SEDLine system has not been checked. In this study, we tested the relationship between desflurane concentration and BIS or PSI, and checked reliability of BIS and PSI during desflurane anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes relationship between desflurane concentration and BIS (BIS monitor) or PSI (SEDLine system)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Stepwise increase in inhalation concentration of desflurane, 3%,4%,and 5%.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patient under desflurane anesthesia
Key exclusion criteria 20 years old<
80 years old>
emergency operation patient
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuo Yamamoto
Organization Kumamoto University Hospital
Division name Anesthesiology
Zip code
Address 1-1-1 Honjyo, Chuo-ku, Kumamoto-shi
TEL 096-373-5275
Email yamyam@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuo Yamamoto
Organization Kumamoto University Hospital
Division name Anesthesiology
Zip code
Address 1-1-1 Honjyo, Chuo-ku, Kumamoto-shi
TEL 096-373-5275
Homepage URL
Email yamyam@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University Hospital
Department of Anesthesiology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 20 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 13 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 08 Month 31 Day
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2018 Year 06 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034242

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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