Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Condition(s) targeted: Spinal Anesthesia; Neonates

Intervention: clonidine (Drug); clonidine (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University Hospital, Montpellier

Official(s) and/or principal investigator(s):
Xavier Capdevila, PhD, Study Chair, Affiliation: CHU de Montpellier, France
Alain Rochette, MD, Principal Investigator, Affiliation: CHU de Montpellier, France

Overall contact:
Alain Rochette, MD, Phone: (33)467338256, Email: a-rochette@chu-montpellier.fr

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.

Official title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

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

Primary outcome: number of "rescue" general anesthesia

Secondary outcome:

apnea and desaturation occurrence

duration of spinal anesthesia

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.

Minimum age: N/A. Maximum age: 60 Weeks. Gender(s): Both.

Criteria:

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.

Alain Rochette, MD, Phone: (33)467338256, Email: a-rochette@chu-montpellier.fr

CHU de Montpellier, Montpellier 34295, France; Recruiting
Alain Rochette, MD, Phone: (33)467338256, Email: a-rochette@chu-montpellier.fr

Related publications:

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.

Rochette A, Troncin R, Raux O, Dadure C, Lubrano JF, Barbotte E, Capdevila X. Clonidine added to bupivacaine in neonatal spinal anesthesia: a prospective comparison in 124 preterm and term infants. Paediatr Anaesth. 2005 Dec;15(12):1072-7.

Starting date: November 2006
Last updated: February 24, 2010