Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01075490
Study type	Interventional
Source	University Hospital, Montpellier
Contact	Alain Rochette, MD
Phone	(33)467338256
Email	a-rochette@chu-montpellier.fr
Status	Recruiting
Phase	Phase 4
Start date	November 2006
Completion date	December 2009

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