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Status unknownNCT01075490Updated Feb 25, 2010

Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

A Phase 4 interventional study of clonidine and clonidine in Spinal Anesthesia and Neonates, sponsored by University Hospital, Montpellier. Status unknown at 1 site in France. Open to participants aged Up to 60 Weeks. Per ClinicalTrials.gov, last updated 2010-02-25.

Sponsored by University Hospital, Montpellier · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2009), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
Up to 60 Weeks
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Spinal Anesthesia
  • Neonates

Keywords

  • spinal anesthesia
  • neonates
  • clonidine
  • post operative apnea
03

In context

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 60 Weeks
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Spinal malformation,
  • Coagulopathy,
  • critical hemodynamics,
  • uncontrolled neurologic or metabolic pathology.
  • infection at injection point.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Placebo comparator
    prematurely born, bupivacaine, placebo

    Drug: clonidine

  • Experimental
    prematurely born, bupivacaine, clonidine

    Drug: clonidine

  • Placebo comparator
    term neonate, bupivacaine, placebo

    Drug: clonidine

  • Experimental
    term neonate, bupivacaine, clonidine

    Drug: clonidine

Interventions

  • Drugclonidine

    addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia

  • Drugclonidine

    equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia

06

What researchers measure

Primary outcomes

  1. number of "rescue" general anesthesia

    Time frame: end of surgery

Secondary outcomes

  1. apnea and desaturation occurrence

    Time frame: during 24h

  2. duration of spinal anesthesia

    Time frame: during 24h

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Study locations

1 of 1 sites recruiting
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References and documents

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):56-59. doi: 10.1213/01.ANE.0000093229.17729.6C. PubMed 14693584 ↗
  • 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. doi: 10.1111/j.1460-9592.2005.01664.x. PubMed 16324026 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01075490
Lead sponsor
University Hospital, Montpellier
First posted
Feb 25, 2010
Start date
Nov 2006
Primary completion
Nov 2006
Completion
Dec 2009 (estimated)
Last update
Feb 25, 2010

Study contacts

Alain Rochette, MD
Contact
a-rochette@chu-montpellier.fr
(33)467338256
Xavier Capdevila, PhD
study chair · CHU de Montpellier, France
Alain Rochette, MD
principal investigator · CHU de Montpellier, France

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.

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