Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
1 other identifier
interventional
120
1 country
1
Brief Summary
This prospective, double blinded study investigates spinal anesthesia with or without clonidine added to bupivacaine in newborns. This study is based on duration measurement of spinal anesthesia and cardio respiratory recording during 24h for apnea detection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Nov 2006
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 12, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Posted
Study publicly available on registry
February 25, 2010
CompletedFebruary 25, 2010
June 1, 2009
Same day
May 12, 2009
February 24, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
number of "rescue" general anesthesia
end of surgery
Secondary Outcomes (2)
apnea and desaturation occurrence
during 24h
duration of spinal anesthesia
during 24h
Study Arms (4)
prematurely born, bupivacaine, placebo
PLACEBO COMPARATORprematurely born, bupivacaine, clonidine
EXPERIMENTALterm neonate, bupivacaine, placebo
PLACEBO COMPARATORterm neonate, bupivacaine, clonidine
EXPERIMENTALInterventions
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Eligibility Criteria
You may qualify if:
- Newborns less than 60 weeks old post-conceptional, former premature or not
- Newborns requiring inguinal hernia or lower limbs surgery,
- infants needing no more critical care assistance
- Informed consent of parents
You may not qualify if:
- Spinal malformation,
- Coagulopathy,
- critical hemodynamics,
- uncontrolled neurologic or metabolic pathology.
- infection at injection point.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Montpellier
Montpellier, 34295, France
Related Publications (2)
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.
PMID: 14693584BACKGROUNDRochette 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.
PMID: 16324026BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xavier Capdevila, PhD
CHU de Montpellier, France
- PRINCIPAL INVESTIGATOR
Alain Rochette, MD
CHU de Montpellier, France
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 12, 2009
First Posted
February 25, 2010
Study Start
November 1, 2006
Primary Completion
November 1, 2006
Study Completion
December 1, 2009
Last Updated
February 25, 2010
Record last verified: 2009-06