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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578174
Other study ID # 4-2011-0928
Secondary ID
Status Completed
Phase N/A
First received April 13, 2012
Last updated January 16, 2018
Start date April 2012
Est. completion date September 2012

Study information

Verified date January 2018
Source Severance Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators examined the effect of dexmedetomidine in the management of pain after uterine artery embolization.


Description:

Leiomyoma are the most common female reproductive tract tumors. Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy. However, post-procedural pain control after UAE remains a major problem. Therefore, the aim of study is to evaluate the efficacy of dexmedetomidine in pain control after UAE.


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility Inclusion Criteria:

- age = 20,

- ASA class I and II

Exclusion Criteria:

- bradycardia (< 45 bpm)

- heart block

- liver failure

- renal failure

- uncontrolled hypertension

- body mass index = 30 kg/m2

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Dexmedetomidine
Dexmedetomidine(Dexmedetomidine 2 mL and normal saline 98 mL mixed -> 2?/mL) : the infusion of 0.2?/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4?/kg/hr after completion of procedure
Normal saline 0.9%
Normal saline 100mL(guess as 2?/mL):the infusion of 0.2?/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4?/kg/hr after completion of procedure

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 Fentanyl consumption by patient-controlled analgesia 24 hours
Secondary Side effects 24 hours
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