Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
24 augustus 2014 bijgewerkt door: Si-Qin Chen
Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
The goal of the present study was to investigate the role of pro-inflammatory cytokines in myocardial dysfunction and injury resulting from noncardiac injury in children and whether or not anti-inflammatory treatment with caudal block prevents pro-inflammatory cytokines-associated myocardial dysfunction and injury following noncardiac surgery.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
40
Fase
- Fase 4
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
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Shanghai, China, 200092
- Werving
- Xinhua Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
1 jaar tot 5 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Children diagnosed for developmental dysplasia of the hip (DDH) undergoing Salter innominate osteotomy will be recruited into the study.
Exclusion Criteria:
- Children with anemia, electrolyte disturbances, abnormal acid-base status, bleeding diathesis, history of allergy to local anesthetics, neurologic and spinal diseases, skin infections on the caudal area, renal dysfunction, symptomatic cardiovascular and respiratory disease
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
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caudal block with 1 ml/kg of ropivacaine 0.2%
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Placebo-vergelijker: saline
caudal block with 1 ml/kg of saline
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caudal block with 1 ml/kg of saline
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Tijdsspanne: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
baseline(before induction of anesthesia), arrival in the postanesthesia care unit
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change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 3h after surgery
|
baseline(before induction of anesthesia), 3h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 24h after surgery
|
baseline(before induction of anesthesia), 24h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 48h after surgery
|
baseline(before induction of anesthesia), 48h after surgery
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change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
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|
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit
Tijdsspanne: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
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change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 3h after surgery
|
baseline(before induction of anesthesia), 3h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 24h after surgery
|
baseline(before induction of anesthesia), 24h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 48h after surgery
|
baseline(before induction of anesthesia), 48h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
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change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit
Tijdsspanne: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
baseline(before induction of anesthesia), arrival in the postanesthesia care unit
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change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 3h after surgery
|
baseline(before induction of anesthesia), 3h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 24h after surgery
|
baseline(before induction of anesthesia), 24h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 48h after surgery
|
baseline(before induction of anesthesia), 48h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
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change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit
Tijdsspanne: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 3h after surgery
|
baseline(before induction of anesthesia), 3h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 24h after surgery
|
baseline(before induction of anesthesia), 24h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 48h after surgery
|
baseline(before induction of anesthesia), 48h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit
Tijdsspanne: baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
baseline(before induction of anesthesia), arrival in the postanesthesia care unit
|
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change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 3h after surgery
|
baseline(before induction of anesthesia), 3h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 24h after surgery
|
baseline(before induction of anesthesia), 24h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 48h after surgery
|
baseline(before induction of anesthesia), 48h after surgery
|
|
change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery
Tijdsspanne: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
Tijdsspanne: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
|
baseline(just before the start of surgery), at arrival in the postanesthesia care unit
|
|
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery
Tijdsspanne: baseline(just before the start of surgery), 3h after surgery
|
baseline(just before the start of surgery), 3h after surgery
|
|
change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit
Tijdsspanne: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
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baseline(just before the start of surgery), at arrival in the postanesthesia care unit
|
|
change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery
Tijdsspanne: baseline(just before the start of surgery), 3h after surgery
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baseline(just before the start of surgery), 3h after surgery
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change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit
Tijdsspanne: baseline(just before the start of surgery), at arrival in the postanesthesia care unit
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baseline(just before the start of surgery), at arrival in the postanesthesia care unit
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change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery
Tijdsspanne: baseline(just before the start of surgery), 3h after surgery
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baseline(just before the start of surgery), 3h after surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 april 2014
Primaire voltooiing (Verwacht)
1 september 2014
Studie voltooiing (Verwacht)
1 oktober 2014
Studieregistratiedata
Eerst ingediend
11 mei 2014
Eerst ingediend dat voldeed aan de QC-criteria
19 mei 2014
Eerst geplaatst (Schatting)
22 mei 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
26 augustus 2014
Laatste update ingediend die voldeed aan QC-criteria
24 augustus 2014
Laatst geverifieerd
1 augustus 2014
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 060717
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .