Adenomyosis Clinical Trial
Official title:
The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization
Verified date | April 2015 |
Source | Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Institutional Review Board |
Study type | Interventional |
The primary purpose of this study is to investigate the effects of dexamethasone on inflammatory reactions after uterine artery embolization. The secondary purpose of this study it to investigate the effects of dexamethasone on postembolization syndrome (severe pain, nasea and vomiting).
Status | Completed |
Enrollment | 64 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 60 Years |
Eligibility |
Inclusion Criteria: - Uterine artery embolization due to multiple myoma or adenomyosis Exclusion Criteria: - Diabetic mellitus - Steroid administration - Liver or kidney dysfuntion - High baseline CRP or leukocytosis (>11,000/µL ) - Drug allergy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory reactions | CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h | 24 hours | Yes |
Secondary | Pain | Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h | 24 hours | Yes |
Secondary | Nausea and vomiting | Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h | 24 hours | Yes |
Secondary | Sucessful rate at 3 month after UAE | Utrerine volume and complete necrosis incidence | 3 month | No |
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