Dexmedetomidine in Off Pump Coronary Artery Bypass Grafting

Study Overview
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Brief Summary
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the study will assess the impact of intraoperative dexmedetomidine infusion on myocardial performance by investigating the left ventricular (LV) systolic and diastolic function and right ventricular (RV) fraction area change (which reflect RV systolic function) using two-dimensional trans-esophageal echocardiography (TEE) in patients undergoing elective first-time isolated off-pump coronary artery bypass (OPCAB) grafting. LV Systolic function will be measured by the TEE via the fractional area change, fraction shortening, and ejection fraction.

Detailed Description
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Off pump coronary revascularization is an old technique performed first in St Petersburg in 1964, Off pump coronary artery surgery has been developed following two different approaches. Minimally invasive direct-access coronary artery bypass (MIDCAB) that consists of anastomosing the left internal mammary artery to the left anterior descending coronary artery through small anterior left thoracotomy, The second approach is multi-vessel grafting without CPB performed through standard median sternotomy. Dexmedetomidine (Dex), a highly selective α2-adrenergic receptor agonist, is widely used for sedation and analgesia in the ICU or as an anesthetic adjuvant. This study will be a prospective comparative controlled randomized double blinded clinical trial on 36 patients divided into control ,and dexmedetomidine group.

Official Title
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Echocardiographic Evaluation of the Effect of Dexmedetomidine Infusion as an Adjuvant to General Anesthesia in Off-pump Coronary Artery Bypass Grafting

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective first-time off-pump isolated coronary artery bypass graft (OPCAB) surgery Patients with good ventricular functions. Patients with normal levels of cardiac troponin I and myocardial enzymes Patients of Body Mass Index (BMI) more than 20 and less than 34. Exclusion Criteria: Severe functional liver or kidney disease. Diagnosed HF (NYHA class >3). Arrhythmia or received treatment with anti-arrhythmic drugs. Severe bradycardia (HR < 45 bpm) and AV block. Pathologic esophageal lesion (esophageal stricture or varix ) Pregnancy.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: dex group<br>patients medicated with dexmedetomidine. | Drug: Dexmedetomidine<br>* infusion of dexmedetomidine during the off pump coronary artery bypass grafting surgery<br>|
| Placebo Comparator: control group<br>patients took placebo normal saline. | Drug: normal saline<br>* infusion of normal saline during the off pump coronary artery bypass grafting surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| left ventricular ejection fraction | using transesophageal echocardiography, ejection fraction will be assessed by the ratio of stroke volume and end diastolic volume | immediatly after sternal closure | 
| left ventricular fractional shorting | using transesophageal echocardiography, fractional area change of the left ventricle will be calculated | immediatly after sternal closure | 
| left ventricular diastolic function | using transesophageal echocardiography, diastolic function (filling ratio) will be assessed by the ratio between early transmitral flow (E) and mitral annular tissue velocity (E'). | immediatly after sternal closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| right ventricular systolic function | right ventricular systolic function assessed by (fraction area change) as assessed using transesophageal echocardiography. | immediatly after sternal closure |