First Version: Study Protocol Authors: Thomaidou E., Vretzakis G., Argiriadou E., Stamatiou G., et al.~Perioperative administration of erythromycin and brain protection~Study Setting: On-pump, planned cardiac surgery. Randomized, double blinded clinical trial of two parallel groups. Group A: control group. Group B: erythromycin group (dose 25mg/kg intravenously).~Purpose:~Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery.~Hypothesis:~The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery.~The aims of this study are:~To determine the effect of high-dose perioperative erythromycin administration on neurological outcome in patients undergoing cardiac surgery~To determine the relationship of neurological monitoring, specifically NIRS, to neurological outcomes and to determine if erythromycin affects this relationship.~Preoperative Period~Patient Exclusion Criteria: patients > 80 years old, cerebrovascular disease with residual deficits, stroke, alcoholism, psychiatric disease.~Preoperative patient neurocognitive status assessment from the same clinical psychologist in all patients:~at least one day before surgery, perform neurocognitive tests.~Patients of group A: 25mg/kg erythromycin intravenously 12 hours before surgery.~Intraoperative Period~Cerebral monitoring: continuous measurement and registration of cerebral oximetry data (NIRS - INVOS), record of frequency and duration of desaturation episodes (a fall >20% compared to baseline values) and record of interventions to correct desaturation.~Anaesthesia depth monitoring: continuous measurement of bispectral index (BIS).~Registration of: duration of CPB and cross clamp time, mean arterial pressure, heart rate, temperature and ETCO2.~Anesthesia Procedures: anesthesia induction with fentanyl 10-15μg/kg, propofol 2gm/kg and rocuronium 0,6mg/kg. Anesthesia maintenance with propofol.~Postoperative Period - ICU~Postoperative patient neurocognitive status assessment from the same clinical psychologist in all patients:~On discharge, and 3 months later perform neurocognitive tests.~Patients of group A: will receive high dose of erythromycin 12 hours after the end of surgery.~Registration of:~Post operative blood loss, duration of ICU stay, mechanical ventilation duration, duration of hospital stay, inotropic support, postoperative myocardial infarction, re-operation, dialysis, neurocognitive decline, other complications.~BIOCHEMICAL INDEX~Blood samples will be taken from all patients for the detection of tau protein, IL-1 and IL-6,~preoperatively~12 hours after surgery~the 6th day after surgery
Neurological complications occur in open heart surgery with a frequency of 40% and they range from major neurological deficits (due to a stroke) to neurocognitive and behavioral disorders. This study aims to determine if erythromycin, a worldwide known antibiotic, protects the brain from damage when given in high doses before and during open heart surgery.~The investigators consume that high dose of erythromycin will protect the brain with a pharmacological preconditioning against the global ischemia during the perioperative period of heart surgery.