ABSTRACT
BACKGROUND: A previous study showed less postoperative neurocognitive impairment in open-chamber cardiac surgery patients given lidocaine for 48 hours after induction of anesthesia. In the present study, we aimed to test the benefit of a 12-hour infusion in a broader group of cardiac surgery patients, including those undergoing coronary artery bypass graft surgery. METHODS: This was a randomized, double-blind, intention-to-treat trial. Before cardiac surgery, 158 patients completed 7 neurocognitive tests and a self-rating scale for memory. They received a 12-hour infusion of either lidocaine in a standard antiarrhythmic dose or placebo, beginning at induction of anesthesia. The cognitive tests and memory scale were repeated at postoperative weeks 10 and 25. A deficit in any cognitive test was defined as a decline in score by more than or equal to the preoperative group standard deviation. RESULTS: All tests were completed by 118 and 107 patients at 10 and 25 weeks, respectively. The proportions of patients in the lidocaine and placebo groups exhibiting a deficit in one or more tests were as follows: 45.8% versus 40.7% at 10 weeks, and 35.2% versus 37.7% at 25 weeks (not significant). There were no significant differences between groups in self-ratings of memory function or length of intensive care unit or hospital stay. CONCLUSIONS: Lidocaine was not neuroprotective. The result of the previous trial may represent a type 1 error. Alternatively, benefit may be more likely for open-chamber surgery patients exposed to larger numbers of emboli or with a longer lidocaine infusion.
Subject(s)
Brain Diseases/etiology , Brain Diseases/prevention & control , Cardiac Surgical Procedures/adverse effects , Cognition Disorders/etiology , Cognition Disorders/prevention & control , Lidocaine/administration & dosage , Double-Blind Method , Female , Follow-Up Studies , Humans , Male , Middle Aged , Time FactorsABSTRACT
BACKGROUND: Bivalirudin is a short-acting direct thrombin inhibitor, with advantages over unfractionated heparin for anticoagulation in cardiac surgery. We hypothesized that bivalirudin is not associated with a clinically important increase in blood loss compared with heparin with protamine reversal in patients undergoing off pump coronary artery bypass (OPCAB) surgery. We also assessed flow with angiography at 3 months using a modified Thombolysis in Myocardial Infarction (TIMI) grade in the grafted coronary arteries. METHODS: One hundred patients were randomly assigned to receive bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg/h infusion) or heparin (150 to 300 U/kg bolus) with protamine reversal. RESULTS: A median of 3 (range, 1 to 5) grafts were inserted per patient. Blood loss for the 12 hours after study drug initiation in the bivalirudin group (median, 793 mL; interquartile range, 532 to 1,214 mL; range, 320 to 4,909 mL; n = 50) was not significantly greater than in the heparin group (median, 805 mL; interquartile range, 517 to 1,117 mL; range, 201 to 2,567 mL; n = 50; p = 0.165). Median graft flow was 3.0 in the bivalirudin group (n = 40) and 2.67 in the heparin group (n = 39; p = 0.047). The bivalirudin group had more patients with grade 3 (ie, full) flow in at least 1 graft (100% versus 90%; p = 0.04), a trend toward more patients with grade 3 flow in all grafts (60% versus 38%; p = 0.06), and more grafts with grade 3 flow (82% versus 67%; p = 0.03). CONCLUSIONS: Anticoagulation for OPCAB surgery with bivalirudin was feasible without a clinically important increase in perioperative blood loss. Graft flow was better in the bivalirudin patients; the impact of this on clinical outcomes requires a larger study.