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

Primary Purpose

Cardiac Dysfunction, Myocardial Injury

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

ropivacaine

saline

About this trial

This is an interventional prevention trial for Cardiac Dysfunction

Eligibility Criteria

1 Year - 5 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Xinhua HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ropivacaine

saline

Arm Description

caudal block with 1 ml/kg of ropivacaine 0.2%

caudal block with 1 ml/kg of saline

Outcomes

Primary Outcome Measures

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 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

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 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

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 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

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery

Secondary Outcome Measures

change from baseline(just before the start of surgery) in MAP(mean arterial pressure) 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

change from baseline(just before the start of surgery) in CVP(central venous pressure) 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

change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit

change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery

Full Information

NCT ID

NCT02144766

First Posted

May 11, 2014

Last Updated

August 24, 2014

Sponsor

Si-Qin Chen

1. Study Identification

Unique Protocol Identification Number

NCT02144766

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

April 2014 (undefined)

Primary Completion Date

September 2014 (Anticipated)

Study Completion Date

October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Si-Qin Chen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Dysfunction, Myocardial Injury

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Ropivacaine

Arm Type

Experimental

Arm Description

caudal block with 1 ml/kg of ropivacaine 0.2%

Arm Title

saline

Arm Type

Placebo Comparator

Arm Description

caudal block with 1 ml/kg of saline

Intervention Type

Drug

Intervention Name(s)

ropivacaine

Intervention Description

caudal block with 1 ml/kg of ropivacaine 0.2%

Intervention Type

Drug

Intervention Name(s)

saline

Intervention Description

caudal block with 1 ml/kg of saline

Primary Outcome Measure Information:

Title

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at arrival in the postanesthesia care unit

Time Frame

baseline(before induction of anesthesia), arrival in the postanesthesia care unit

Title

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 3h after surgery

Time Frame

baseline(before induction of anesthesia), 3h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 24h after surgery

Time Frame

baseline(before induction of anesthesia), 24h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 48h after surgery

Time Frame

baseline(before induction of anesthesia), 48h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of NT(N terminal)-proBNP at 72h after surgery

Time Frame

baseline(before induction of anesthesia), 72h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at arrival in the postanesthesia care unit

Time Frame

baseline(before induction of anesthesia), arrival in the postanesthesia care unit

Title

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 3h after surgery

Time Frame

baseline(before induction of anesthesia), 3h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 24h after surgery

Time Frame

baseline(before induction of anesthesia), 24h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 48h after surgery

Time Frame

baseline(before induction of anesthesia), 48h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of CK(creatine kinase)-MB at 72h after surgery

Time Frame

baseline(before induction of anesthesia), 72h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at arrival in the postanesthesia care unit

Time Frame

baseline(before induction of anesthesia), arrival in the postanesthesia care unit

Title

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 3h after surgery

Time Frame

baseline(before induction of anesthesia), 3h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 24h after surgery

Time Frame

baseline(before induction of anesthesia), 24h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 48h after surgery

Time Frame

baseline(before induction of anesthesia), 48h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of cTn(troponin)I at 72h after surgery

Time Frame

baseline(before induction of anesthesia), 72h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at arrival in the postanesthesia care unit

Time Frame

baseline(before induction of anesthesia), arrival in the postanesthesia care unit

Title

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 3h after surgery

Time Frame

baseline(before induction of anesthesia), 3h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 24h after surgery

Time Frame

baseline(before induction of anesthesia), 24h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 48h after surgery

Time Frame

baseline(before induction of anesthesia), 48h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of TNF(tumor necrosis factor)-α at 72h after surgery

Time Frame

baseline(before induction of anesthesia), 72h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at arrival in the postanesthesia care unit

Time Frame

baseline(before induction of anesthesia), arrival in the postanesthesia care unit

Title

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 3h after surgery

Time Frame

baseline(before induction of anesthesia), 3h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 24h after surgery

Time Frame

baseline(before induction of anesthesia), 24h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 48h after surgery

Time Frame

baseline(before induction of anesthesia), 48h after surgery

Title

change from baseline(before induction of anesthesia) in plasma concentrations of IL(interleukin)-6 at 72h after surgery

Time Frame

baseline(before induction of anesthesia), 72h after surgery

Secondary Outcome Measure Information:

Title

change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at arrival in the postanesthesia care unit

Time Frame

baseline(just before the start of surgery), at arrival in the postanesthesia care unit

Title

change from baseline(just before the start of surgery) in MAP(mean arterial pressure) at 3h after surgery

Time Frame

baseline(just before the start of surgery), 3h after surgery

Title

change from baseline(just before the start of surgery) in CVP(central venous pressure) at arrival in the postanesthesia care unit

Time Frame

baseline(just before the start of surgery), at arrival in the postanesthesia care unit

Title

change from baseline(just before the start of surgery) in CVP(central venous pressure) at 3h after surgery

Time Frame

baseline(just before the start of surgery), 3h after surgery

Title

change from baseline(just before the start of surgery) in HR(heart rate) at arrival in the postanesthesia care unit

Time Frame

baseline(just before the start of surgery), at arrival in the postanesthesia care unit

Title

change from baseline(just before the start of surgery) in HR(heart rate) at 3h after surgery

Time Frame

baseline(just before the start of surgery), 3h after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

5 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

SiQin Chen, MD

Phone

+8613918085974

chensiqin1983@hotmail.com

Facility Information:

Facility Name

Xinhua Hospital

City

Shanghai

ZIP/Postal Code

200092

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

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

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