Status Approved
First Submitted Date
2015/10/13
Registered Date
2015/10/16
Last Updated Date
2016/07/26
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0001664 |
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Unique Protocol ID | 20150918/16-2015-136/101 |
Public/Brief Title | Effect of central obesity on the level of blockade during spinal anesthesia |
Scientific Title | Effect of central obesity on the level of blockade during spinal anesthesia |
Acronym | |
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 | 20150918/16-2015-136/101 |
Approval Date | 2015-10-12 |
Institutional Review Board Name | Ethics commttee of Seoul Metropolitan Goverment Seoul National University Boramae Medical Center |
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 | Jin-Young Hwang |
Title | M.D. Ph.D. |
Telephone | +82-2-870-2518 |
Affiliation | Seoul Metropolitan Government Seoul National University Boramae Medical Center |
Address | 425 Shindaebangdong Dongjakgu Seoul |
Contact Person for Public Queries | |
Name | Jin-Young Hwang |
Title | M.D. Ph.D. |
Telephone | +82-2-870-2518 |
Affiliation | Seoul Metropolitan Government Seoul National University Boramae Medical Center |
Address | 425 Shindaebangdong Dongjakgu Seoul |
Contact Person for Updating Information | |
Name | Jin-Young Hwang |
Title | M.D. Ph.D. |
Telephone | +82-2-870-2518 |
Affiliation | Seoul Metropolitan Government Seoul National University Boramae Medical Center |
Address | 425 Shindaebangdong Dongjakgu Seoul |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Completed | |
Date of First Enrollment | 2015-11-10 Actual | |
Target Number of Participant | 58 | |
Primary Completion Date | 2016-07-15 , Actual | |
Study Completion Date | 2016-07-15 , Actual | |
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Seoul Metropolitan Government Seoul National University Boramae Medical Center | |
Recruitment Status | Completed | |
Date of First Enrollment | 2015-11-10 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Seoul Metropolitan Government Seoul National University Boramae Medical Center |
Organization Type | Medical Institute |
Project ID | 20150918/16-2015-136 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Seoul Metropolitan Government Seoul National University Boramae Medical Center |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | The aim of this study is to evaluate the effect of waist circumference (presence of central obesity) on the sensory and motor blockade, time to achieve maximal level of bockade, and the duration of spinal blockde during spinal anesthesia. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-only |
Time Perspective | Cross-sectional |
Target Number of Participant | 58 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label Waist circumference <85 cm |
Cohort/Group Description After the induction of spinal anesthesia, sensory and motor blockade, time to maximal blockade, duration of blockade are recorded. |
|
Cohort/ Group 2 |
Cohort/Group Label Waist circumference ≥85 cm |
Cohort/Group Description After the induction of spinal anesthesia, sensory and motor blockade, time to maximal blockade, duration of blockade are recorded. |
|
Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Female patients older than 60 yrs of age undergoing sinal anestheisa |
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Sampling Method | Patients scheduled for elective surgery under spinal anesthesia are screened. |
Condition(s)/Problem(s) |
* (E00-E90)Endocrine, nutritional and metabolic diseases (E66.9)Obesity, unspecified |
Rare Disease | No |
Inclusion Criteria |
Gender Female |
Age 61Year~No Limit |
|
Description Female patients older than 60 yrs of age undergoing sinal anestheisa |
|
Exclusion Criteria |
BMI < 23 or > 27.5 kg/m2 Height < 150 cm or >170 cm Spinal deformity (ex. ankylosing spondylitis) |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | /Safety/Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | Maximal sensory blockade level |
|
Timepoint | After the induction of spinal anesthesia |
|
Secondary Outcome(s) 1 | ||
Outcome | Duration of sensory and motor blockade |
|
Timepoint | From the inductin of spinal anestheia to the time for sensory blockade level L2, motor score 0 |
|
Secondary Outcome(s) 2 | ||
Outcome | Occurrence of hypotension |
|
Timepoint | Durig spnal anesthesia |
|
Secondary Outcome(s) 3 | ||
Outcome | Ephedrine requirement |
|
Timepoint | Duing spinal anesthesia |
|
Secondary Outcome(s) 4 | ||
Outcome | Occurrence of bradycardia |
|
Timepoint | During spinal anesthesia |
|
Secondary Outcome(s) 5 | ||
Outcome | Incience of nausea and vomiting |
|
Timepoint | During spinal anesthesia |
|
Secondary Outcome(s) 6 | ||
Outcome | Mean arterial pressure, Heart rate |
|
Timepoint | After the induction of spinal anesthesia, every 1 min for 20 min, and then every 5 min for 40 min |
|
Secondary Outcome(s) 7 | ||
Outcome | Maximum motor blockade level |
|
Timepoint | After the induction of spinal anesthesia |
|
Secondary Outcome(s) 8 | ||
Outcome | Time to achieve maximal sensory blockade |
|
Timepoint | After the induction of spinal anesthesia |
|
Secondary Outcome(s) 9 | ||
Outcome | Time to achieve maximal motor blockade |
|
Timepoint | After the induction of spinal anesthesia |
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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