Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
24. august 2014 oppdatert av: 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.
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Shanghai, Kina, 200092
- Rekruttering
- Xinhua Hospital
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 år til 5 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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%
|
|
Placebo komparator: saline
caudal block with 1 ml/kg of saline
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caudal block with 1 ml/kg of saline
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Tidsramme: 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 NT(N terminal)-proBNP at 3h after surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 NT(N terminal)-proBNP at 72h after surgery
Tidsramme: 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 CK(creatine kinase)-MB at arrival in the postanesthesia care unit
Tidsramme: 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 CK(creatine kinase)-MB at 3h after surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 cTn(troponin)I at arrival in the postanesthesia care unit
Tidsramme: 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 cTn(troponin)I at 3h after surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 IL(interleukin)-6 at 3h after surgery
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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 CVP(central venous pressure) at 3h after surgery
Tidsramme: 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 HR(heart rate) at arrival in the postanesthesia care unit
Tidsramme: 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 HR(heart rate) at 3h after surgery
Tidsramme: baseline(just before the start of surgery), 3h after surgery
|
baseline(just before the start of surgery), 3h after surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2014
Primær fullføring (Forventet)
1. september 2014
Studiet fullført (Forventet)
1. oktober 2014
Datoer for studieregistrering
Først innsendt
11. mai 2014
Først innsendt som oppfylte QC-kriteriene
19. mai 2014
Først lagt ut (Anslag)
22. mai 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
26. august 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
24. august 2014
Sist bekreftet
1. august 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 060717
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