Use of Dexamethasone in Uterine Artery Embolization

Adenomyosis Clinical Trial

Official title:

The Effect of Dexamethasone on Inflammatory Response After Uterine Artery Embolization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02056717
• Other study ID #: 4-2013-0863
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: April 15, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenomyosis
• Leiomyoma
• Uterine Myoma

Intervention

Drug:
• Dexamethasone
Administration of dexamethasone 10 mg IV 1 h before UAE
• Normal saline
Administration of normal saline 2 mL IV 1 h before UAE

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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