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Effect of Dexmedetomidine on the Characteristics of High Volume/Low Concentration Ropivacaine in a Caudal Block in Pediatrics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163980
Recruitment Status : Completed
First Posted : June 16, 2014
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
The investigators perform this study to evaluate the effects of caudal Dexmedetomidine (DEX) added to high volume/low-concentration of ropivacaine in children undergoing orchiopexy.

Condition or disease Intervention/treatment Phase
Ambulatory Orchipexy Drug: Caudal ropivacaine + normal saline Drug: Caudal ropivacaine + dexmedetomidine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : May 2011
Actual Primary Completion Date : May 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Caudal ropivacaine + normal saline
1.5ml kg-1 ropivacaine 0.15% with normal saline (Control group, n=40).
Drug: Caudal ropivacaine + normal saline
Experimental: Caudal ropivacaine + dexmedetomidine
1.5ml kg-1 ropivacaine 0.15% with dexmedetomidine 1 μg kg-1 (DEX group, n=40)
Drug: Caudal ropivacaine + dexmedetomidine



Primary Outcome Measures :
  1. vital sign [ Time Frame: up to 180 min after surgery ]
    systolic arterial pressure


Secondary Outcome Measures :
  1. inhalation anesthetics requirements [ Time Frame: up to 180 min after surgery ]
    end-tidal sevoflurane concentration required to maintain hemodynamic changes < 20% of the preoperative baseline


Other Outcome Measures:
  1. incidence of agitation [ Time Frame: up to 180 min after surgery ]
    number of patients

  2. sedation score [ Time Frame: up to 180 min after surgery ]
    three-point scale (0=eyes open spontaneously, 1=verbal stimulation, 2=physical stimulation

  3. pain scores [ Time Frame: up to 180 min after surgery ]
    Face Legs Activity Cry, Consolability scale (FLACC) Children's Hospital of Eastern Ontario Pain Scale (CHEOPS)



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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • children undergoing ambulatory orchiopexy,
  • ASA status I

Exclusion Criteria:

  • mental retardation,
  • developmental delay,
  • neurological or psychiatric illness,
  • coagulation disorder,
  • spinal anomalies

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): NCT02163980


Locations
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Korea, Republic of
Yonsei Univ. College of Medicine Dep. Of Anesthesiology
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02163980    
Other Study ID Numbers: 4-2011-0111
First Posted: June 16, 2014    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014
Keywords provided by Yonsei University:
dexmedetomidine
caudal block
children
children (1-6 years) undergoing ambulatory orchipexy
Additional relevant MeSH terms:
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Dexmedetomidine
Ropivacaine
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
Anesthetics, Local
Anesthetics