Use of Dexamethasone in Uterine Artery Embolization

Not Applicable

Completed

• Conditions: Adenomyosis; Uterine Myoma
• Interventions: Drug: Normal saline; Drug: Dexamethasone

• Registration Number: NCT02056717
• Lead Sponsor: Severance Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-05
• Study First Posted: 2014-02-06
• Study Start: 2014-04
• Status Verified: 2015-04
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Normal saline	-
Dexamethasone group	Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Inflammatory reactions	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

Name	Time	Method
Nausea and vomiting	24 hours	Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
Sucessful rate at 3 month after UAE	3 month	Utrerine volume and complete necrosis incidence
Pain	24 hours	Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of