Spinal Anesthesia | Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Spinal Anesthesia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Exclusion Criteria: - Spinal malformation, - Coagulopathy, - critical hemodynamics, - uncontrolled neurologic or metabolic pathology. - infection at injection point.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:clonidineaddition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Drug:clonidineequivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
prematurely born, bupivacaine, placebo
prematurely born, bupivacaine, clonidine
term neonate, bupivacaine, placebo
term neonate, bupivacaine, clonidine
Start Date: November 2006
Completed Date: December 2009
Phase: Phase 4
Primary Outcome: number of "rescue" general anesthesia
Secondary Outcome: apnea and desaturation occurrence
Study sponsors, principal investigator, and references
Principal Investigator: Xavier Capdevila, PhD
Lead Sponsor: University Hospital, Montpellier
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):56-9, table of contents.