Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
- Registration Number
- NCT01075490
- Lead Sponsor
- University Hospital, Montpellier
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description term neonate, bupivacaine, clonidine clonidine - prematurely born, bupivacaine, placebo clonidine - prematurely born, bupivacaine, clonidine clonidine - term neonate, bupivacaine, placebo clonidine -
- Primary Outcome Measures
Name Time Method number of "rescue" general anesthesia end of surgery
- Secondary Outcome Measures
Name Time Method apnea and desaturation occurrence during 24h duration of spinal anesthesia during 24h
Trial Locations
- Locations (1)
CHU de Montpellier
🇫🇷Montpellier, France