Neonates, Spinal Anesthesia
Conditions
Keywords
spinal anesthesia, neonates, clonidine, post operative apnea
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.
Detailed description
Ex premies and term neonates are two subgroups investigated separately. The overall objective is to validate lengthening of spinal anesthesia in newborns in order to avoid rescue general anesthesia that occur in 20-40 % of patients with plain bupivacaine.
Interventions
DRUGclonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Weeks
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of rescue general anesthesia | end of surgery |
Secondary
| Measure | Time frame |
|---|---|
| apnea and desaturation occurrence | during 24h |
| duration of spinal anesthesia | during 24h |
Countries
France
Contacts
Primary ContactAlain Rochette, MD
Outcome results
None listed