This study involves patients who are having planned heart surgery to repair or replace heart valves or to bypass blocked coronary arteries. During these operations, a heart-lung machine, also called cardiopulmonary bypass, is used to temporarily take over the work of the heart and lungs. This machine can trigger a body-wide inflammatory response, which is the body’s reaction to injury or stress, and this response can sometimes lead to problems after surgery such as kidney injury, infection, organ dysfunction, bleeding, low blood pressure, breathing difficulties, and brain-related issues. The study will test whether giving lidocaine through a vein during and after surgery can reduce this inflammatory response. Lidocaine is a medication commonly used as a local painkiller, but it may also have effects that calm down inflammation in the body. Patients will receive either lidocaine or placebo, which is a solution that looks the same but contains only sodium chloride, a salt water solution.
The purpose of the study is to find out whether lidocaine given through a vein can lower the levels of a substance called interleukin-6 in the blood six hours after surgery ends. Interleukin-6 is a marker of inflammation in the body, and high levels of it are associated with the inflammatory response caused by the heart-lung machine. The study will also measure other markers of inflammation and heart stress, including C-reactive protein, high-sensitivity Troponin T, and TNF-α, at different times before, during, and after surgery. Additionally, the study will look at whether patients who receive lidocaine have fewer complications after surgery, spend less time in the intensive care unit, have better survival rates one month after surgery, and experience less pain in the days following the operation.
Patients in the study will be randomly assigned to receive either lidocaine or placebo during their surgery and for a period afterward. Neither the patients nor the doctors will know which treatment is being given, which helps ensure fair and accurate results. Blood samples will be taken at specific times to measure the inflammation markers, and information about any complications, length of stay in the intensive care unit, heart rhythm problems after the heart is restarted, pain levels, and need for pain medication will be collected. The study is expected to begin enrolling patients in October 2025 and continue until April 2027.



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