Status Approved
First Submitted Date
2017/09/14
Registered Date
2017/11/17
Last Updated Date
2018/01/17
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0002542 |
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Unique Protocol ID | SCHUH 2017-05-018-001 |
Public/Brief Title | Assessment of Phase Lag Entropy(PLE) monitor for the sedation levels using propofol |
Scientific Title | Assessment of Phase Lag Entropy(PLE) monitor for the sedation levels using propofol in upper limb surgery patients under brachial plexus block |
Acronym | PLE |
MFDS Regulated Study | No |
IND/IDE Protocol | No |
Registered at Other Registry | No |
Healthcare Benefit Approval Status |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | SCHUH 2017-05-018-001 |
Approval Date | 2017-07-06 |
Institutional Review Board Name | Institutional Review Board of Soonchunhyang Universty Seoul Hospital |
Institutional Review Board Address | |
Institutional Review Board Telephone | |
Data Monitoring Committee | No |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Soon Im Kim |
Title | professor |
Telephone | +82-2-709-9294 |
Affiliation | Soon Chun Hyang University |
Address | 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea |
Contact Person for Public Queries | |
Name | Soon Im Kim |
Title | professor |
Telephone | +82-2-709-9294 |
Affiliation | Soon Chun Hyang University |
Address | 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea |
Contact Person for Updating Information | |
Name | Soon Im Kim |
Title | professor |
Telephone | +82-2-709-9294 |
Affiliation | Soon Chun Hyang University |
Address | 22 Soonchunhyang-Ro, Asan city, Chungchungnamdo, Korea |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-07-12 Actual | |
Target Number of Participant | 30 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Soon Chun Hyang University Hospital Seoul | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2017-07-12 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | InBody |
Organization Type | Others |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Soon Chun Hyang University Hospital Seoul |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The aim of this study is to assess the Phase Lag Entropy(PLE) monitor for the sedation levels using propofol in upper limb surgery patients under brachial plexus block. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Prospective |
Target Number of Participant | 30 |
Cohort/Group Number | 1 |
Cohort/ Group 1 |
Cohort/Group Label PLE group |
Cohort/Group Description we assess the corrrelation of OAA/S Scale and PLE index, and comparison PLE with BIS to assess the sedation level. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | adult patients ( >18 yr old) who undergoing upper arm surgery under brachial plexus block using ultrasonogram Healthy patient who is American Society of Anesthesiology (ASA) physical status 1or 2. |
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Sampling Method | purposive sapling |
Condition(s)/Problem(s) | Not Applicable-Anesthesia |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 19Year~No Limit |
|
Description adult patients ( >18 yr old) who undergoing upper arm surgery under brachial plexus block using ultrasonogram Healthy patient who is American Society of Anesthesiology (ASA) physical status 1or 2. |
|
Exclusion Criteria |
-patient who has CNS disease, past history of CNS disease, and neurological disorder - patient who has been taken anticonvulsant agent, sedatives, analgesics, and hypnotics . - significant hepatic disease or renal disease - obesity (BMI>30) _ Obstructive sleep apnea - hypersensitivity to propofol or local anesthetics - hypersensitivity to bean or peanut _ pregnant woman |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | correlation of OAA/S Scale and PLE |
|
Timepoint | propofol로 진정시킬 때 |
|
Secondary Outcome(s) 1 | ||
Outcome | comparison PLE with BIS |
|
Timepoint | propofol로 진정시킬 때 |
11. Study Results and Publication
Result Registered |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Not provided at time of Registration |
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