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Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

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ClinicalTrials.gov Identifier: NCT01075490
Recruitment Status : Unknown
Verified June 2009 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : February 25, 2010
Last Update Posted : February 25, 2010
Sponsor:
Information provided by:
University Hospital, Montpellier

May 12, 2009
February 25, 2010
February 25, 2010
November 2006
November 2006   (Final data collection date for primary outcome measure)
number of "rescue" general anesthesia [ Time Frame: end of surgery ]
Same as current
No Changes Posted
  • apnea and desaturation occurrence [ Time Frame: during 24h ]
  • duration of spinal anesthesia [ Time Frame: during 24h ]
Same as current
Not Provided
Not Provided
 
Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Spinal Anesthesia
  • Neonates
  • 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
  • Placebo Comparator: prematurely born, bupivacaine, placebo
    Intervention: Drug: clonidine
  • Experimental: prematurely born, bupivacaine, clonidine
    Intervention: Drug: clonidine
  • Placebo Comparator: term neonate, bupivacaine, placebo
    Intervention: Drug: clonidine
  • Experimental: term neonate, bupivacaine, clonidine
    Intervention: Drug: clonidine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
120
Same as current
December 2009
November 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
up to 60 Weeks   (Child)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01075490
UF7874
Yes
Not Provided
Not Provided
Alain Rochette, University Hospital of Montpellier
University Hospital, Montpellier
Not Provided
Study Chair: Xavier Capdevila, PhD CHU de Montpellier, France
Principal Investigator: Alain Rochette, MD CHU de Montpellier, France
University Hospital, Montpellier
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP