Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

University Hospital, Montpellier120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Spinal Anesthesia Neonates

Interventions

clonidineDRUG

addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia

clonidineDRUG

equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia

Eligibility

Sex: ALLMax age: 60 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

CHU de Montpellier

Montpellier, France

RECRUITING

Outcomes

Primary Outcomes

number of "rescue" general anesthesia

Time frame: end of surgery

Secondary Outcomes

apnea and desaturation occurrence

Time frame: during 24h

duration of spinal anesthesia

Time frame: during 24h

Central Contacts

Alain Rochette, MD

CONTACT

(33)467338256 a-rochette@chu-montpellier.fr

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.