Use of Dexamethasone in Uterine Artery Embolization

N/ACompletedNCT02056717

Severance Hospital64 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Uterine Myoma Adenomyosis

Interventions

DexamethasoneDRUG

Administration of dexamethasone 10 mg IV 1 h before UAE

Normal salineDRUG

Administration of normal saline 2 mL IV 1 h before UAE

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Seoul, South Korea

Outcomes

Primary Outcomes

Inflammatory reactions

CRP, WBC, neutrophil (%), cortisol : pre-UAE, post-UAE 12 h, post-UAE-24 h IL-6 : pre-UAE, post-UAE-24 h

Time frame: 24 hours

Secondary Outcomes

Pain

Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h

Time frame: 24 hours

Nausea and vomiting

Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h

Time frame: 24 hours

Sucessful rate at 3 month after UAE

Utrerine volume and complete necrosis incidence

Time frame: 3 month

Data from ClinicalTrials.gov

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