The Effect of Dexmedetomidine in the Management of Pain After Uterine Artery Embolization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital
ClinicalTrials.gov Identifier:
NCT01578174
First received: April 13, 2012
Last updated: October 31, 2012
Last verified: October 2012

April 13, 2012
October 31, 2012
April 2012
September 2012   (final data collection date for primary outcome measure)
Fentanyl consumption by patient-controlled analgesia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01578174 on ClinicalTrials.gov Archive Site
Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effect of Dexmedetomidine in the Management of Pain After Uterine Artery Embolization
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Pain Control
  • 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
  • Drug: 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
  • Placebo Comparator: Control
    Intervention: Drug: Normal saline 0.9%
  • Active Comparator: Dexmedetomidine
    Intervention: Drug: Dexmedetomidine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01578174
4-2011-0928
No
So Yeon Kim, Severance Hospital
Severance Hospital
Not Provided
Not Provided
Severance Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP