Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
NCT ID: NCT01075490
Last Updated: 2010-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
120 participants
INTERVENTIONAL
2006-11-30
2009-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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prematurely born, bupivacaine, placebo
clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
prematurely born, bupivacaine, clonidine
clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
term neonate, bupivacaine, placebo
clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
term neonate, bupivacaine, clonidine
clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Interventions
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clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Eligibility Criteria
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Inclusion Criteria
* Newborns requiring inguinal hernia or lower limbs surgery,
* infants needing no more critical care assistance
* Informed consent of parents
Exclusion Criteria
* Coagulopathy,
* critical hemodynamics,
* uncontrolled neurologic or metabolic pathology.
* infection at injection point.
60 Weeks
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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University Hospital of Montpellier
Principal Investigators
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Xavier Capdevila, PhD
Role: STUDY_CHAIR
CHU de Montpellier, France
Alain Rochette, MD
Role: PRINCIPAL_INVESTIGATOR
CHU de Montpellier, France
Locations
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CHU de Montpellier
Montpellier, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Rochette A, Raux O, Troncin R, Dadure C, Verdier R, Capdevila X. Clonidine prolongs spinal anesthesia in newborns: a prospective dose-ranging study. Anesth Analg. 2004 Jan;98(1):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C.
Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7. doi: 10.1111/j.1460-9592.2005.01664.x.
Other Identifiers
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UF7874
Identifier Type: -
Identifier Source: org_study_id
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