Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
24 augusti 2014 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
40
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Shanghai, Kina, 200092
- Rekrytering
- Xinhua Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 år till 5 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
|
caudal block with 1 ml/kg of ropivacaine 0.2%
|
|
Placebo-jämförare: saline
caudal block with 1 ml/kg of saline
|
caudal block with 1 ml/kg of saline
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline(before induction of anesthesia), 72h after surgery
|
baseline(before induction of anesthesia), 72h after surgery
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: baseline(just before the start of surgery), 3h after surgery
|
baseline(just before the start of surgery), 3h after surgery
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 april 2014
Primärt slutförande (Förväntat)
1 september 2014
Avslutad studie (Förväntat)
1 oktober 2014
Studieregistreringsdatum
Först inskickad
11 maj 2014
Först inskickad som uppfyllde QC-kriterierna
19 maj 2014
Första postat (Uppskatta)
22 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 augusti 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 augusti 2014
Senast verifierad
1 augusti 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 060717
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .