Comparison of Milrinone and Epinephrine on TAPSE

Mansoura University

Status: Not yet enrolling

Conditions: Cardiac Anaesthesia; Cardiopulmonary Bypass

Treatments: Drug: Epinephrine; Drug: Milrinone Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT07144267

Milrinone on TAPSE

Details and patient eligibility

About

Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.

Full description

Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.

Milrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists (ASA) physical status II & III
• Age between 18 and 70 years
• Both Gender
• Body mass index less than 40 kg/m2
• Ejection fraction of >40%
• Tricuspid annular plane systolic excursion (TAPSE) < 1.7cm

Exclusion criteria

• Patient refusal.
• Preoperative RV impairment
• Pulmonary hypertension (estimated pulmonary artery systolic pressure > 50 mmHg)
• Patients with any contraindications to Transesophageal echocardiography (TEE)
• Redo or Re-exploration surgery
• Patients with chronic kidney disease (serum creatinine > 1.5 mg/ dl)
• Patients with chronic liver disease (child pugh B and C)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups

Epinephrine group (group E)

Active Comparator group

Description:

The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping

Treatment:

Drug: Epinephrine

Milrinone group (group M)

Active Comparator group

Description:

patients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping

Treatment:

Drug: Milrinone Injection