UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029983 |
|---|---|
| Receipt number | 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 | 2020/11/17 10:16:47 |
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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 | Tatsuo |
| Middle name | |
| Last name | Yamamoto |
Organization
Kumamoto University Hospital
Division name
Anesthesiology
Zip code
860-8556
Address
1-1-1 Honjyo, Chuo-ku, Kumamoto-shi
TEL
096-373-5275
yamyam@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yamamoto |
| Middle name | |
| Last name | Tatsuo |
Organization
Kumamoto University Hospital
Division name
Anesthesiology
Zip code
860-8556
Address
1-1-1 Honjyo, Chuo-ku, Kumamoto-shi
TEL
096-373-5275
Homepage URL
yamyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University Hospital
Department of Anesthesiology
Institute
Department
Personal name
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
Kumamoto University Hospital, Ethical Committee
Address
1-1-1 Honjo, Chuo-ku, Kumamoto-shi, Kumamoto
Tel
0963735275
yamyam@kumamoto-u.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 | 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
Completed
Date of protocol fixation
| 2017 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 15 | Day |
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
| 2020 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034242
