Dexmedetomidine Sedation and Cardiopulmonary Bypass

Study Overview
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Brief Summary
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Dexmedetomidine is a unique sedative anesthetic agent that allows accurate control of the depth of sedation and provides analgesia, cardio protection, renal protection, and neuroprotection without causing respiratory depression. It is an alpha 2-adrenoreceptor agonist that modulates the release of catecholamines from the central and autonomic nervous systems. When patients sedated by dexmedetomidine are allowed to become responsive, they are calm and cooperative (1). No other sedative agent has this feature, and sedated patients frequently awaken in a confused state. Investigators are conducting this study project to compare between dexmedetomidine based and propofol based anesthetic techniques with regard to hemodynamic changes, stress hormone release as well as cytokines in patients undergoing CPB for coronary revascularization.

Detailed Description
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100 patients undergoing elective CPB for coronary revascularization surgery. On the morning of operation the patients were randomized to receive one of two anesthetic techniques dependent on the type of sedation used. Standard anesthetic technique will be used for all patients except for using dexmedetomidine sedation in one group and propofol sedation in the other group.

Official Title
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Dexmedetomidine Based Versus Propofol Based Anesthesia in Patients Undergoing Coronary Revascularization: a Randomized, Double-blind Controlled Study

Conditions
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Coronary Artery Bypass Grafting

Intervention / Treatment
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* Drug: Dexmedetomidine
* Drug: propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients scheduled for elective coronary revascularization surgery with cardiopulmonary bypass Exclusion Criteria: Severely impaired left ventricular function (ejection fraction <40%) Valvular heart disease Low cardiac output syndrome Uncontrolled rapid atrial fibrillation On plavix less than one week Severe systemic non-cardiac disease Infectious disease Poorly controlled diabetes mellitus patients on corticosteroids or other immunosuppressive treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Dexmedetomidine group<br> | Drug: Dexmedetomidine<br>* Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.<br>* Other names: precedex;|
| Active Comparator: Propofol group<br> | Drug: propofol<br>* Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.<br>* Other names: diprivan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac index | cardiac index measured in L/min/m2 | within intraoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate | heart rate measured in beat/min. | within intraoperative period | 
| mean arterial blood pressure | mean arterial blood pressure measured in mm.Hg | within intraoperative period | 
| central venous pressure | central venous pressure measured in mm.Hg | within intraoperative period | 
| pulmonary capillary wedge pressure | pulmonary capillary wedge pressure measured in mm.Hg | within intraoperative period | 
| mean pulmonary artery pressure | mean pulmonary artery pressure measure in mm.Hg | within intraoperative period | 
| systemic vascular resistance index | systemic vascular resistance index measured in dyn.sec/cm5/m2 | within intraoperative period | 
| pulmonary vascular resistance index | pulmonary vascular resistance index measured in dyn.sec/cm5/m2 | within intraoperative period | 
| stroke volume index | stroke volume index measured in ml/m2/beat | within intraoperative period | 
| left ventricular stroke work index | left ventricular stroke work index measured in gm/m2/beat | within intraoperative period | 
| cardiac output | cardiac output measured in L/min | within intraoperative period | 
| inotrope score | appropriate score | 1st 24 hours | 
| duration of mechanical ventilation | duration of mechanical ventilation measured in hours | 1st week | 
| sedation score | appropriate score | 1st 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomidine, Cardiac, Coronary Artery Bypass Grapht, Sedation, Propofol, Intravenous Anesthetics