Cardiac Dysfunction, Myocardial Injury
Conditions
Brief summary
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.
Interventions
DRUGropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
DRUGsaline
caudal block with 1 ml/kg of saline
Sponsors
Si-Qin Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Years to 5 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 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 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 | 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 | 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 | 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 | 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 | baseline(before induction of anesthesia), 48h after surgery |
| change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline(before induction of anesthesia), 24h after surgery |
Secondary
| Measure | Time frame |
|---|---|
| change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 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 | 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 | 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 | 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 | baseline(just before the start of surgery), 3h after surgery |
| change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit | baseline(just before the start of surgery), at arrival in the postanesthesia care unit |
Countries
China
Contacts
Primary ContactSiQin Chen, MD
Outcome results
None listed