Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block
24. august 2014 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
40
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Shanghai, Kina, 200092
- Rekruttering
- Xinhua hospital
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
1 år til 5 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
|
caudal block with 1 ml/kg of ropivacaine 0.2%
|
|
Placebo komparator: saline
caudal block with 1 ml/kg of saline
|
caudal block with 1 ml/kg of saline
|
Hvad måler undersøgelsen?
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. april 2014
Primær færdiggørelse (Forventet)
1. september 2014
Studieafslutning (Forventet)
1. oktober 2014
Datoer for studieregistrering
Først indsendt
11. maj 2014
Først indsendt, der opfyldte QC-kriterier
19. maj 2014
Først opslået (Skøn)
22. maj 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 060717
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Myokardieskade
-
NYU Langone HealthNational Heart, Lung, and Blood Institute (NHLBI)RekrutteringMyocardial skade efter ikke -hjertekirurgiForenede Stater
-
Truway Health, Inc.Tilmelding efter invitationEvaluering af In-Vitro Cryo Terapeutiske Protokoller på Humane Celleprøver (TWH-CRYO-001) (CRYO-IVT)Cellular Injury and Post-Cryogenic Recovery | Kryogenisk cellulær stress | Kuldeinduceret cellulær skade | Termisk Skade Reaktion | Post-thaw levedygtighedsforringelse | Osmotisk Stressskade | Biomekanisk Skadesmodellering (In-Vitro) | Blunt Force Injuries to the Extremities (Cellular Injury Model) | Vævsskade... og andre forholdForenede Stater
-
Hospital Universitari Son DuretaEspen; This research prize was funded by Nestle Nutrition Institute and...AfsluttetModerat til alvorligt traume, som defineret af en | Injury Severity Score (ISS) > 12 point var inkluderet i undersøgelsen.Spanien
-
Sichuan Provincial People's HospitalTilmelding efter invitationRest Gated Myocardial Perfusion Imaging ved hjertesvigtKina
-
Azienda Ospedaliero Universitaria Maggiore della...Università degli Studi del Piemonte Orientale "Amedeo Avogadro"Rekruttering
-
Fondazione Policlinico Universitario Agostino Gemelli...Afsluttet
-
Peking University Third HospitalAfsluttet
-
Stanford UniversityAfsluttetMyocardial brodannelseForenede Stater
-
Izmir Bakircay UniversityAfsluttetMyokardiebro af kranspulsårenKalkun
-
ITAB - Institute for Advanced Biomedical TechnologiesAzienda Ospedaliero, Universitaria Ospedali RiunitiAfsluttetMyokardiebro af kranspulsårenItalien
Kliniske forsøg med ropivacaine
-
Northern Jiangsu People's HospitalIkke rekrutterer endnu
-
Sahiwal medical college sahiwalAfsluttetBradykardi | Postoperativ analgesi | Opioidbesparende anæstesi | Hypotension, kontrolleret | StomitilbageførselsprocedurePakistan
-
Huazhong University of Science and TechnologyRekrutteringNerveblok | Ropivacain | Liposomal bupivacain | Total knæantroplastikKina
-
Qilu Hospital of Shandong UniversityRekrutteringAnalgesi | Liposomal bupivacain | Præperitoneal infiltrationKina
-
Ziekenhuis Oost-LimburgRekrutteringAnæstesi | Hallux ValgusBelgien
-
University Health Network, TorontoUkendtSmerter, postoperativCanada
-
Boston Children's HospitalTrukket tilbageSmerter, postoperativ | Hoftedysplasi | Regional anæstesiForenede Stater
-
Pusan National University HospitalAfsluttetHæmodynamik | Epidural anæstesi | Ropivacain koncentrationKorea, Republikken
-
Beijing Tiantan HospitalIkke rekrutterer endnuSøvn | Stellat ganglieblok | Langvarige bevidsthedsforstyrrelserKina