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Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by University Hospital, Montpellier.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01075490
First received: May 12, 2009
Last updated: February 24, 2010
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Spinal Anesthesia
Neonates
 Drug: clonidine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • number of "rescue" general anesthesia [ Time Frame: end of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • apnea and desaturation occurrence [ Time Frame: during 24h ] [ Designated as safety issue: Yes ]
  • duration of spinal anesthesia [ Time Frame: during 24h ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: November 2006
Estimated Study Completion Date: December 2009
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 60 Weeks
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Alain Rochette, University Hospital of Montpellier
ClinicalTrials.gov Identifier: NCT01075490     History of Changes
Other Study ID Numbers: UF7874
Study First Received: May 12, 2009
Last Updated: February 24, 2010
Health Authority: France: Institutional Ethical Committee

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
 Antihypertensive Agents
Cardiovascular Agents
Sympatholytics
Autonomic Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics

ClinicalTrials.gov processed this record on May 23, 2013