Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Study Overview
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Brief Summary
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Perioperative myocardial injury remains one of the most serious complications of cardiac surgery. Numerous factors have been implicated during the pathogenesis process, including the technique of cardiac surgery, induction of cardioplegia and period of cardiac arrest. Lactic acid is the normal endpoint of the anaerobic breakdown of glucose in the tissues. The lactate exits the cells and is transported to the liver, thus it's considered to be an indicator of ischemia as it is produced by most tissues in the human body, with the highest level of production found in muscle. In any cardiac valve replacement surgery, patient must undergo cardiac bypass and arrest in diastole by using hyperkalemic cardioplegia solution; meanwhile the metabolism of myocardial cells is purely anaerobic. Esmolol an ultra-short beta blocker is supposed to decrease the anaerobic insult to the myocardial cells.

Official Title
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Outcome of Esmolol Potassium Cardioplegia Compared to Potassium Cardioplegia in Patients With Solitary Valvular Disease; Randomized Controlled Study

Conditions
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Cardioplegia Solution Adverse Reaction

Intervention / Treatment
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* Drug: Esmolol
* Drug: Potassium Cardioplegic Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 20-50 years old patients, with either sex with solitary valvular disease Exclusion Criteria: • Myocardial infarction within 2 weeks. History of reaction or toxicity to esmolol or other beta blockers. New York Heart Association class IV congestive heart failure despite treatment. Persistent hypotension (systolic blood pressure <80 mm Hg). severe pulmonary hypertension Ejection fraction less than 45% Patients with coronary artery disease Patients with congenital heart disease Patients with previous cardiac surgery Patients with liver disease (child class B and C) Patients with second or third degree heart block Patients having resting heart rate less than 50 ppm Patients using calcium channel blockers

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Drug: Potassium Cardioplegic Solution<br>* 15 meq potassium added to cardioplegia solution<br>|
| Experimental: Esmolol<br> | Drug: Esmolol<br>* esmolol 250 mg in cardioplegia solution every 25 minutes<br>Drug: Potassium Cardioplegic Solution<br>* 15 meq potassium added to cardioplegia solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary sinus lactate level immediately before declamping the aorta. | the lactate from the coronary sinus | 1 hour during declamping |