Evaluation of the Effect of Intravenous Lidocaine on the Systemic Inflammatory Response Associated With Cardiopulmonary Bypass in Valvular and/or Coronary Cardiac Surgery: Protocol for a Double-Blind Randomized Clinical Trial.

OBJECTIVES

To assess whether intravenous lidocaine reduces the systemic inflammatory response associated with cardiopulmonary bypass (CPB) and improves clinical outcomes in adult patients undergoing elective valvular and/or coronary cardiac surgery.

DESIGN

Single-center, parallel-group, double-blind, randomized clinical trial.

SETTING

San Pedro University Hospital, Logroño, Spain.

PARTICIPANTS

Ninety adult patients (≥18 years) scheduled for elective valvular and/or coronary surgery with CPB who provide informed consent.

INTERVENTIONS: Patients will be randomly assigned to receive either intravenous lidocaine (1.5-mg/kg bolus followed by 1.5-mg/kg/h infusion until sternal closure) or an equivalent volume of saline solution as placebo. For patients with a body mass index greater than 30 kg/m², the infusion dose will be adjusted according to ideal body weight, calculated as height (in centimeters) - 100 for men and height (in centimeters) - 110 for women.

MEASUREMENTS AND MAIN

RESULTS

The primary outcome is the interleukin 6 level at 6 hours postoperatively. Secondary outcomes include trajectories of inflammatory and myocardial injury biomarkers (C-reactive protein, high-sensitivity troponin T, and tumor necrosis factor α), postoperative complications related to the systemic inflammatory response (acute kidney injury, transfusion requirements, vasoplegia, respiratory dysfunction, delirium, infection, and multiorgan dysfunction), postoperative pain, intensive care unit length of stay, 30-day mortality, and incidence of post-CPB atrial fibrillation. The analysis will be conducted on an intention-to-treat basis.

CONCLUSIONS

This trial will determine whether intravenous lidocaine attenuates the systemic inflammatory response induced by CPB and improves clinical outcomes in adult patients undergoing elective cardiac surgery.