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

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ClinicalTrials.gov Identifier: NCT01578174
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

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

Condition or disease Intervention/treatment Phase
Pain Control Drug: Dexmedetomidine Drug: Normal saline 0.9% Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Study Start Date : April 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Fentanyl consumption by patient-controlled analgesia [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Side effects [ Time Frame: 24 hours ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: So Yeon Kim, Clinical assistant professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT01578174     History of Changes
Other Study ID Numbers: 4-2011-0928
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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