Effect of Dexmedetomidine on Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

Study Overview
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Brief Summary
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50 patients of both sexes undergoing elective CABG surgery will be randomly divided into 2 groups, study group (Dex) group and control group (C) to determine the effect of dexmedetomidine on the peri-operative hemodynamic changes during CABG surgery.

Detailed Description
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The effect of dexmedetomidine during CABG surgery is studied regarding Ventricular function, pre bypass and post bypass using the transoeophageal echo (TEE), post-operative by transthoracic echocardiography (TTE) on day of surgery and after extubation. Incidence of intraoperative and post operative ischemia and arrhythmias using Electrocardiogram (ECG) as well as the length of ICU and hospital stay.

Official Title
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Effect of Dexmedetomidine on Stress-induced Changes in Hemodynamics and Left Ventricular Function in Coronary Artery Bypass Graft Surgery Outcome

Conditions
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Effect of Drug in CABAG Patients

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing elective CABG surgery Exclusion Criteria: Patient refusal Dementia patients Poor ventricular function with ejection fraction below 40% Asthmatic patients Uncontrolled diabetic patients with HbA1c above 8 Combined surgeries (CABG+ valves) Emergency surgeries. Pre-existing arrhythmia Patients with renal impairment Patients with hepatic impairment Patients with heart block Off-pump CABG

Ages Eligible for Study
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Minimum Age: 30 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine group<br>patients will have loading Dexmedetomidine( 1ug/kg) over 10 minutes followed by continuous infusion of (0.5ug/kg/hr) from the initiation of anaesthesia up to extubation in the ICU. Patients will not be extubated until completely awake and have no sign of arrhythmias and bleeding | Drug: Dexmedetomidine<br>* a central sympatholytic drug<br>* Other names: precedex;|
| Placebo Comparator: control group<br>patients will receive the same volume of 0.9% saline infusion as loading and maintenance infusion. | Other: normal saline<br>* saline is given to control group<br>* Other names: saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative ventricular function. | global systolic function Ejection Fraction by TEE intraoperative | Intraoperative | 
| post-operative ventricular function. | global systolic function Ejection Fraction by TTE postoperative | Up to 24 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamics | Heart Rate (beat/minute), | Immediate postoperative and up to 24 hours postoperative | 
| hemodynamics | Mean arterial blood pressure (mmHg) | Immediate postoperative and up to 24 hours postoperative |