Prevention of Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block

Myocardial Injury Clinical Trial

Official title:

Prevention of Pro-inflammatory Cytokines-associated Myocardial Dysfunction and Injury Resulting From Salter Innominate Osteotomy by Caudal Block

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02144766
• Other study ID #: 060717
• Status: Recruiting
• Phase: Phase 4
• First received: May 11, 2014
• Last updated: August 24, 2014
• Start date: April 2014
• Est. completion date: October 2014

Study information

• Verified date: August 2014
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: SiQin Chen, MD
• Phone: +8613918085974
• Email: chensiqin1983[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Dysfunction
• Myocardial Injury

Intervention

Drug:
• ropivacaine
caudal block with 1 ml/kg of ropivacaine 0.2%
• saline
caudal block with 1 ml/kg of saline

Locations

Country	Name	City	State
China	Xinhua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Si-Qin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-a at arrival in the postanesthesia care unit		baseline(before induction of anesthesia), arrival in the postanesthesia care unit	No
Primary	change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-a at 3h after surgery		baseline(before induction of anesthesia), 3h after surgery	No
Primary	change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-a at 24h after surgery		baseline(before induction of anesthesia), 24h after surgery	No
Primary	change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-a at 48h after surgery		baseline(before induction of anesthesia), 48h after surgery	No
Primary	change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-a at 72h after surgery		baseline(before induction of anesthesia), 72h after surgery	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No