Protective Effects of Dexmedetomidine on Myocardial Injury During Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the protective effect of dexmedetomidine on myocardial injury during liver transplantation

Detailed Description
-----------------
Liver transplantation surgery may lead to myocardial injury. Dexmedetomidine, a highly specific α2-adrenoeptor agonist, has sedative and analgesic properties without significant respiratory depression at the clinically approved dosage. Some investigations indicated that dexmedetomidine was able to protect the myocardium via improving the activity of Na+-K+-adenosine triphosphate enzyme and Ca2+-adenosine triphosphate, alleviating inflammation reaction and avoiding Ca2+ overload. However, the effect and the mechanism of dexmedetomidine on myocardial injury during liver transplantation remain unclear.

Conditions
-----------------
Evidence of Liver Transplantation, Myocardial Injury

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage liver disease scheduled for liver transplantation in Tianjin First Center Hospital Exclusion Criteria: Pre-existing respiratory failure,renal failure,hepatic encephalopathy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine Group<br>Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation. | Drug: Dexmedetomidine<br>* Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.<br>|
| Placebo Comparator: Normal saline Group<br>Equal volume normal saline substitute for dexmedetomidine | Drug: Normal saline<br>* Equal volume normal saline substitute for dexmedetomidine<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-operative mortality |  | through study completion, an average of 5 weeks | 
| The incidence of cardiac complications |  | from anesthesia induction to 24 hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidences of Clinically Definite Myocardial Injury Confirmed by Electrochemiluminescence | myohemoglobin,creatine kinase isoenzyme,cardiac troponinⅠ,Heart-type fatty acid-binding protein | before skin incision, 0.5 hour min after anhepatic, 2 hours of neohepatic stage,the end of surgery,24 hours after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dexmedetomidine