Study on Propofol and Remifentanil for Patients with Heart Disease Undergoing Cardiac Anesthesia with Cardiopulmonary Bypass

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What is this study about?

This clinical trial is focused on studying the effects of two medications, Propofol and Remifentanil, during heart surgeries that involve the use of a heart-lung machine, known as cardiopulmonary bypass. The diseases being studied include valvular heart disease, coronary heart disease, and aortic disorders. The purpose of the study is to evaluate a model that predicts how these medications behave in the body during surgery. This model is called the Eleveld Pharmacokinetic Model.

Participants in the study will receive either Propofol or Remifentanil through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will compare the actual levels of these medications in the blood with the levels predicted by the model. This will help determine if the model can accurately predict how the medications work during surgery. The study will also involve a placebo group to compare results.

The trial will last for a short period, focusing on the time during and immediately after the surgery. The researchers will collect data on the concentration of the medications in the blood and compare it to the predictions made by the model. This information will help improve the understanding of how these medications can be used safely and effectively during heart surgeries. The study aims to ensure that the model’s predictions are within an acceptable range, which will help in providing better anesthesia care for patients undergoing these types of surgeries.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as age between 18 and 90 years, and the need for elective cardiac surgery with cardiopulmonary bypass.

Informed consent is required to participate in the study.

2 preparation for anesthesia

Before surgery, preparation involves understanding the use of medications such as propofol and remifentanil.

Propofol is administered as an emulsion for injection or infusion, while remifentanil is prepared as a solution for injection or infusion.

3 administration of medications

During the procedure, propofol and remifentanil are administered intravenously to maintain anesthesia.

The administration is guided by the Eleveld Pharmacokinetic Model to predict the concentration of these medications in the body.

4 monitoring during surgery

Throughout the surgery, the concentration of propofol and remifentanil is measured and compared to predicted values.

The primary goal is to ensure that the prediction error remains within an acceptable range, which is between -20% and +20%.

5 evaluation of anesthesia depth

The depth of anesthesia is continuously monitored using various parameters such as BIS, SEF, SR, and ST values.

These values help describe the effectiveness of anesthesia and ensure patient safety.

6 post-surgery analysis

After the surgery, the agreement between measured and predicted concentrations of propofol and remifentanil is evaluated.

Secondary analyses include comparing the intraoperative area under the curve (AUC) for these medications and assessing the analgesic depth using NOL and PPI values.

7 completion of trial participation

The study aims to conclude by December 31, 2025, with ongoing evaluations to ensure the accuracy and safety of the pharmacokinetic model used.

Who Can Join the Study?

The patient must be scheduled for elective cardiac surgery. This means the surgery is planned in advance and is not an emergency.
The surgery must involve cardiopulmonary bypass, a procedure where a machine temporarily takes over the function of the heart and lungs during surgery.
The patient must be between the ages of 18 and 90 years.
The patient must provide informed consent, which means they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

People with valvular heart disease cannot participate. This is a condition where the heart valves, which help blood flow in the right direction, are not working properly.
People with coronary heart disease cannot participate. This is a condition where the blood vessels that supply blood to the heart become narrow or blocked.
People with aortic disorders cannot participate. The aorta is the main artery that carries blood from the heart to the rest of the body, and disorders can affect its function.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Medical University Of Vienna	Vienna	Austria

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Propofol is a medication used to help patients relax and fall asleep before and during surgery. It is often used in anesthesia to keep patients unconscious and pain-free during procedures. In this trial, propofol is being studied to see how well its concentration in the body can be predicted during cardiac surgery.

Remifentanil is a strong painkiller used during surgery to help manage pain and keep patients comfortable. It is often used alongside other medications to provide anesthesia. This trial is examining how accurately the levels of remifentanil can be predicted in patients undergoing heart surgery with the help of a specific pharmacokinetic model.

Investigated diseases:

Aortic disorder

Valvular Heart Disease – This condition involves damage to one or more of the heart’s valves, which can affect blood flow through the heart. The disease can lead to the valves not opening or closing properly, causing blood to leak backward or flow in the wrong direction. Over time, this can result in the heart working harder to pump blood, potentially leading to heart enlargement or heart failure. Symptoms may include shortness of breath, fatigue, and swelling in the legs or feet. The progression of the disease can vary, with some individuals experiencing rapid changes while others may have a more gradual progression.

Coronary Heart Disease – This disease occurs when the coronary arteries, which supply blood to the heart muscle, become narrowed or blocked. This is often due to a buildup of cholesterol and other substances, known as plaque, on the artery walls. As the disease progresses, it can reduce blood flow to the heart, leading to chest pain or discomfort, known as angina. If a coronary artery becomes completely blocked, it can result in a heart attack. The progression of coronary heart disease can be slow and may go unnoticed until significant artery blockage occurs.

Aortic Disorders – These disorders involve the aorta, the largest artery in the body, which carries blood from the heart to the rest of the body. Aortic disorders can include conditions such as aortic aneurysm, where the aorta becomes abnormally large or balloons outward, and aortic dissection, where there is a tear in the aorta’s inner layer. These conditions can lead to serious complications if the aorta ruptures or tears further. Symptoms may include sudden chest or back pain, difficulty breathing, or loss of consciousness. The progression of aortic disorders can vary, with some conditions remaining stable for years while others may progress rapidly.

Trial ID:

2023-507808-31-00

Protocol code:

ELEVALUATE

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Propofol and Remifentanil for Patients with Heart Disease Undergoing Cardiac Anesthesia with Cardiopulmonary Bypass

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?