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Completed

NCT Number: NCT02056717

Use of Dexamethasone in Uterine Artery Embolization

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).

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Key information

Conditions

Uterine Myoma Adenomyosis Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Skin and Connective Tissue Diseases Urogenital Diseases Uterine Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Administration of dexamethasone 10 mg IV 1 h before UAE

normal saline

Drug

Administration of normal saline 2 mL IV 1 h before UAE

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Severance Hospital

Other

Registry information

Official study title

The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Feb 6, 2014
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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