Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

University Hospital Center (CHU)

Status and phase: Unknown; Phase 4

Conditions: Neonates; Spinal Anesthesia

Treatments: Drug: clonidine

Study type: Interventional

Funder types: Other

Identifiers

NCT01075490

UF7874

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: Under 60 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups, including a placebo group

prematurely born, bupivacaine, placebo

Placebo Comparator group

Treatment:

Drug: clonidine

Drug: clonidine

prematurely born, bupivacaine, clonidine

Experimental group

Treatment:

Drug: clonidine

Drug: clonidine

term neonate, bupivacaine, placebo

Placebo Comparator group

Treatment:

Drug: clonidine

Drug: clonidine

term neonate, bupivacaine, clonidine

Experimental group

Treatment:

Drug: clonidine

Drug: clonidine