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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
History of Changes
  Purpose

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


Condition Intervention
Pain Control
 Drug: Dexmedetomidine
Drug: Normal saline 0.9%

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Severance Hospital:

Primary Outcome Measures:
  • Fentanyl consumption by patient-controlled analgesia [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Side effects [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 66
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control 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
Active Comparator: Dexmedetomidine 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578174

Locations
Korea, Republic of
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
  More Information

No publications provided

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01578174     History of Changes
Other Study ID Numbers: 4-2011-0928
Study First Received: April 13, 2012
Last Updated: October 31, 2012
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013