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Use of Dexamethasone in Uterine Artery Embolization

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ClinicalTrials.gov Identifier: NCT02056717
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Uterine Myoma Adenomyosis Drug: Dexamethasone Drug: Normal saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Dexamethasone group Drug: Dexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE
Placebo Comparator: Control group Drug: Normal saline
Administration of normal saline 2 mL IV 1 h before UAE


Outcome Measures
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Primary Outcome Measures :
  1. Inflammatory reactions [ Time Frame: 24 hours ]
    CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h


Secondary Outcome Measures :
  1. Pain [ Time Frame: 24 hours ]
    Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h

  2. Nausea and vomiting [ Time Frame: 24 hours ]
    Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h

  3. Sucessful rate at 3 month after UAE [ Time Frame: 3 month ]
    Utrerine volume and complete necrosis incidence


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056717


Locations
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Korea, Republic of
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Severance Hospital
More Information
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Responsible Party: So Yeon Kim, Assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT02056717    
Other Study ID Numbers: 4-2013-0863
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Leiomyoma
Myofibroma
Adenomyosis
Uterine Diseases
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Dexamethasone
 Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents