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Clinical Trials/NCT01075490
NCT01075490
Unknown
Phase 4

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

University Hospital, Montpellier1 site in 1 country120 target enrollmentNovember 2006
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ConditionsSpinal AnesthesiaNeonates
Interventionsclonidine
Drugsclonidine

Overview

Phase
Phase 4
Intervention
clonidine
Conditions
Spinal Anesthesia
Sponsor
University Hospital, Montpellier
Enrollment
120
Locations
1
Primary Endpoint
number of "rescue" general anesthesia
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
November 2006
End Date
December 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility 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.

Arms & Interventions

prematurely born, bupivacaine, placebo

Intervention: clonidine

prematurely born, bupivacaine, clonidine

Intervention: clonidine

term neonate, bupivacaine, placebo

Intervention: clonidine

term neonate, bupivacaine, clonidine

Intervention: clonidine

Outcomes

Primary Outcomes

number of "rescue" general anesthesia

Time Frame: end of surgery

Secondary Outcomes

  • duration of spinal anesthesia(during 24h)
  • apnea and desaturation occurrence(during 24h)

Study Sites (1)

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