NCT01075490

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 60 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Spinal Anesthesia
• Neonates

Interventions

Type	Name	Description
DRUG	clonidine	addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
DRUG	clonidine	equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia

Timeline

• Start date: 2006-11-01
• Primary completion: 2006-11-01
• Completion: 2009-12-01
• First posted: 2010-02-25
• Last updated: 2010-02-25

Locations

1 site across 1 country: France