Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
24 sierpnia 2014 zaktualizowane przez: 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.
Przegląd badań
Status
Nieznany
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
40
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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-
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Shanghai, Chiny, 200092
- Rekrutacyjny
- Xinhua Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
1 rok do 5 lat (Dziecko)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: Ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
|
caudal block with 1 ml/kg of ropivacaine 0.2%
|
|
Komparator placebo: saline
caudal block with 1 ml/kg of saline
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caudal block with 1 ml/kg of saline
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
|---|---|
|
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
|
Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
|---|---|
|
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: baseline(just before the start of surgery), 3h after surgery
|
baseline(just before the start of surgery), 3h after surgery
|
Współpracownicy i badacze
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Sponsor
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 kwietnia 2014
Zakończenie podstawowe (Oczekiwany)
1 września 2014
Ukończenie studiów (Oczekiwany)
1 października 2014
Daty rejestracji na studia
Pierwszy przesłany
11 maja 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
19 maja 2014
Pierwszy wysłany (Oszacować)
22 maja 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
26 sierpnia 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
24 sierpnia 2014
Ostatnia weryfikacja
1 sierpnia 2014
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 060717
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .