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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

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.

Condition or disease Intervention/treatment Phase
Spinal Anesthesia Neonates Drug: clonidine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
Study Start Date : November 2006
Actual Primary Completion Date : November 2006
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: prematurely born, bupivacaine, placebo Drug: clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Experimental: prematurely born, bupivacaine, clonidine Drug: clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
Placebo Comparator: term neonate, bupivacaine, placebo Drug: clonidine
equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
Experimental: term neonate, bupivacaine, clonidine Drug: clonidine
addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia



Primary Outcome Measures :
  1. number of "rescue" general anesthesia [ Time Frame: end of surgery ]

Secondary Outcome Measures :
  1. apnea and desaturation occurrence [ Time Frame: during 24h ]
  2. duration of spinal anesthesia [ Time Frame: during 24h ]


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Ages Eligible for Study:   up to 60 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075490


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

Locations
France
CHU de Montpellier Recruiting
Montpellier, France, 34295
Contact: Alain Rochette, MD    (33)467338256    a-rochette@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Chair: Xavier Capdevila, PhD CHU de Montpellier, France
Principal Investigator: Alain Rochette, MD CHU de Montpellier, France

Publications:
Responsible Party: Alain Rochette, University Hospital of Montpellier
ClinicalTrials.gov Identifier: NCT01075490     History of Changes
Other Study ID Numbers: UF7874
First Posted: February 25, 2010    Key Record Dates
Last Update Posted: February 25, 2010
Last Verified: June 2009

Keywords provided by University Hospital, Montpellier:
spinal anesthesia
neonates
clonidine
post operative apnea

Additional relevant MeSH terms:
Anesthetics
Bupivacaine
Clonidine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Analgesics
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action