Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Spinal Anesthesia Clinical Trial

Official title:

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01075490
• Other study ID #: UF7874
• Status: Recruiting
• Phase: Phase 4
• First received: May 12, 2009
• Last updated: February 24, 2010
• Start date: November 2006
• Est. completion date: December 2009

Study information

• Verified date: June 2009
• Source: University Hospital, Montpellier
• Contact: Alain Rochette, MD
• Phone: (33)467338256
• Email: a-rochette[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2009
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 60 Weeks

Eligibility

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.

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

• Neonates
• Spinal Anesthesia

Intervention

Drug:
• clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
• clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of "rescue" general anesthesia		end of surgery	No
Secondary	apnea and desaturation occurrence		during 24h	Yes
Secondary	duration of spinal anesthesia		during 24h	Yes