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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

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).

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nitroglycerin

nitroglycerin titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

nitroglycerin

Intervention Type DRUG

nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

Esmolol

esmolol titrated to control hypertension between anesthesia induction and initiation of cardiopulmonary bypass

Group Type ACTIVE_COMPARATOR

esmolol

Intervention Type DRUG

esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Interventions

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nitroglycerin

nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.

Intervention Type DRUG

esmolol

esmolol will be administered by infusion following a step up / step down protocol to control hypertension.

Intervention Type DRUG

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

1. severe LV (left ventricle)dysfunction (EF \< 35%).
2. emergency procedures.
3. procedures with combined carotid artery surgery.
4. patients at high risk for stroke.
5. hemodynamically significant dysrhythmias.
6. pre-existing atrial fibrillation or high degree AV (atrioventricular block).
7. pacemaker dependency.
8. known sensitivity to beta blockers.
9. patient refusal.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No