Official Title: “Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine”

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.

Study Type: Interventional

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

Study Primary Completion Date: November 2006

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: prematurely born, bupivacaine, placebo
• Experimental: prematurely born, bupivacaine, clonidine
• Placebo Comparator: term neonate, bupivacaine, placebo
• Experimental: term neonate, bupivacaine, clonidine

Primary Measures

• number of "rescue" general anesthesia
  • Time Frame: end of surgery
    Safety Issue?: No

Secondary Measures

• apnea and desaturation occurrence
  • Time Frame: during 24h
    Safety Issue?: Yes
• duration of spinal anesthesia
  • Time Frame: during 24h
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 60 Weeks

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Montpellier

Overall Clinical Trial Officials and Contacts

Xavier Capdevila, PhD Study Chair CHU de Montpellier, France  

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

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01075490

Study ID Number: UF7874

ClinicalTrials.gov Identifier: NCT01075490

Health Authority: France: Institutional Ethical Committee