Use of Dexamethasone in Uterine Artery Embolization

Sponsor

Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02056717

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Apr 1, 2014

Actual Primary Completion Date :

Apr 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

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

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

Primary Outcome Measures

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

Pain [24 hours]
Immediately after UAE, post-UAE 1, 2, 4, 6, 8, 12, 24 h
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

So Yeon Kim, Assistant professor, Severance Hospital

ClinicalTrials.gov Identifier:

NCT02056717

Other Study ID Numbers:

4-2013-0863

First Posted:

Feb 6, 2014

Last Update Posted:

Apr 17, 2015

Last Verified:

Apr 1, 2015

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 17, 2015