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

Study Description

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 Design

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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

Drug Information available for: Clonidine Clonidine hydrochloride

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

number of "rescue" general anesthesia [ Time Frame: end of surgery ]

Secondary Outcome Measures :

apnea and desaturation occurrence [ Time Frame: during 24h ]
duration of spinal anesthesia [ Time Frame: during 24h ]

Eligibility Criteria

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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.

Contacts and Locations

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

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

Locations

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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

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Study Chair:	Xavier Capdevila, PhD	CHU de Montpellier, France
Principal Investigator:	Alain Rochette, MD	CHU de Montpellier, France

More Information

Publications:

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.

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.

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Responsible Party:	Alain Rochette, University Hospital of Montpellier
ClinicalTrials.gov Identifier:	NCT01075490
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:

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Clonidine Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antihypertensive Agents Sympatholytics	Autonomic Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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