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Spinal Anesthesia | Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine

Spinal Anesthesia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Spinal Anesthesia

Neonates

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:clonidineaddition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia

Drug:clonidineequivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

prematurely born, bupivacaine, placebo

prematurely born, bupivacaine, clonidine

term neonate, bupivacaine, placebo

term neonate, bupivacaine, clonidine

Study Status

Unknown status

Start Date: November 2006

Completed Date: December 2009

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: number of "rescue" general anesthesia

Secondary Outcome: apnea and desaturation occurrence

Study sponsors, principal investigator, and references

Principal Investigator: Xavier Capdevila, PhD

Lead Sponsor: University Hospital, Montpellier

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01075490

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.

Discuss Clonidine