Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass (CPB) in Cardiac Surgery

Study Overview
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Brief Summary
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This is an investigator initiated, sponsored, open label, prospective randomized controlled trial to be performed in adult patients undergoing scheduled cardiac surgery. Patients will be randomized to esmolol infusion or nitroglycerin infusion for control of hypertension that occurs during cardiac surgery from induction of anesthesia to initiation of cardiopulmonary bypass (CPB).

Official Title
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Esmolol or Nitroglycerin Infusion for Blood Pressure Control Prior to Cardiopulmonary Bypass(CPB) in Cardiac Surgery: a Randomized, Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Drug: nitroglycerin
* Drug: esmolol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult patients scheduled for cardiac surgery at LLUMC University Hospital will be eligible for participation in this study. Exclusion Criteria: severe LV (left ventricle)dysfunction (EF < 35%). emergency procedures. procedures with combined carotid artery surgery. patients at high risk for stroke. hemodynamically significant dysrhythmias. pre-existing atrial fibrillation or high degree AV (atrioventricular block). pacemaker dependency. known sensitivity to beta blockers. patient refusal.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nitroglycerin<br>nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass | Drug: nitroglycerin<br>* nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.<br>|
| Active Comparator: Esmolol<br>esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass | Drug: esmolol<br>* esmolol will be administered by infusion following a step up / step down protocol to control hypertension.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour | Area under the curve (AUC) of Diastolic Blood Pressure Excursions Beyond Predetermined Lower Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Title: Systolic Hypertension | Area under the curve (AUC) of Systolic Blood Pressure Excursions Beyond Predetermined Upper Limits, Normalized Per Hour from Anesthesia Induction to Initiation of Cardiopulmonary Bypass | Participants were followed from Anesthesia Induction to Initiation of Cardiopulmonary Bypass, an average of 5 hours |