Study on the Effects of Epinephrine, Norepinephrine, and Phenylephrine on Heart Function During Major Abdominal Surgery

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What is this study about?

This clinical trial is focused on patients undergoing open major abdominal surgery. The study aims to understand the effects of three medications: epinephrine, norepinephrine, and phenylephrine on the heart’s performance during surgery. These medications are used to support blood pressure and heart function. Epinephrine, also known as adrenaline, is a medication that can increase heart rate and blood flow. Norepinephrine, also called noradrenaline, helps to narrow blood vessels and increase blood pressure. Phenylephrine is another medication that can increase blood pressure by narrowing blood vessels.

The purpose of the study is to compare how these medications affect the heart’s ability to pump blood during surgery. Participants will receive one of these medications through an intravenous infusion, which means the medication is given directly into a vein. The study is designed to be double-blinded, meaning neither the participants nor the researchers know which medication each participant is receiving, to ensure unbiased results. The study will also look at how these medications affect oxygen levels in the brain and other tissues during surgery.

Participants in the study will be monitored throughout their surgery to measure the heart’s performance and oxygen levels. The study will help determine which medication provides the best support for patients undergoing major abdominal surgery. This information could improve the care and outcomes for patients in similar situations in the future.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, which is to evaluate the effect of three medications on heart function during surgery.

You will be asked to provide consent to participate in the study.

2 preparation for surgery

Before your surgery, you will undergo a series of assessments to ensure you meet the study’s criteria. This includes confirming your age, medical history, and risk factors.

You will be prepared for surgery as per standard medical procedures.

3 medication administration

During your surgery, you will receive one of the following medications through an intravenous infusion: phenylephrine hydrochloride, epinephrine hydrochloride, or noradrenaline tartrate.

The specific medication and dosage will be determined randomly, and neither you nor the medical team will know which medication you are receiving to ensure unbiased results.

4 monitoring during surgery

Throughout the surgery, your heart function and oxygen levels in your brain and tissues will be closely monitored.

The main focus is on the time-weighted average of your heart’s output, as well as the oxygen saturation levels in your brain and tissues.

5 post-surgery follow-up

After the surgery, you will be monitored for any immediate effects of the medication and your recovery will be observed.

You may be asked to attend follow-up appointments to assess your recovery and gather additional data for the study.

Who Can Join the Study?

Must be 45 years old or older.
Scheduled for a moderate- to high-risk major open abdominal surgery that is expected to last at least 2 hours.
Must have an ASA physical status of 2 or higher. (ASA physical status is a system used to assess the fitness of patients before surgery, with higher numbers indicating more health issues.)
Must have at least one of the following risk factors:
- Age 75 years or older
- History of peripheral arterial disease (a condition affecting blood flow in the arteries)
- History of coronary artery disease (a condition affecting blood flow to the heart)
- History of stroke or transient ischemic attack (a temporary period of symptoms similar to those of a stroke)
- History of chronic kidney disease (long-term kidney damage)
- Diabetes that requires medical treatment
- Current smoking or a history of smoking at least 15 pack-years (a pack-year is smoking 20 cigarettes a day for one year)
- History of heart failure (a condition where the heart doesn’t pump blood as well as it should)
- Preoperative high-sensitivity Troponin T level of 14 ng/L or higher (a blood test that measures heart muscle damage)
- Preoperative NT-proBNP level of 200 pg/mL or higher (a blood test that measures heart stress)

Who Cannot Join the Study?

Patients who are not undergoing open major abdominal surgery cannot participate. This means the surgery involves a large incision in the belly area.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population cannot participate. This includes groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

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	Not recruiting	18.09.2022

Trial locations

Investigated drugs:

Epinephrine is a medication that helps to increase the heart rate and improve blood flow. It is often used in medical settings to help the heart work better, especially during surgery. In this trial, epinephrine is being studied to see how it affects the heart’s performance during operations.

Norepinephrine is a medication that is used to increase blood pressure and improve blood flow. It works by narrowing blood vessels, which helps to raise blood pressure. This medication is being tested in the trial to understand its impact on heart function during surgery.

Phenylephrine is a medication that is used to increase blood pressure by tightening blood vessels. It is often used to help maintain stable blood pressure during surgery. In this trial, phenylephrine is being evaluated to see how it affects the heart’s performance while a patient is undergoing an operation.

Postoperative Complications – Postoperative complications refer to a range of issues that can occur after undergoing surgery. These complications can affect various systems in the body, including the cardiovascular, respiratory, and digestive systems. Common complications include infections, bleeding, and delayed healing of the surgical site. Cardiovascular complications may involve changes in heart rate or blood pressure, while respiratory issues can include difficulty breathing or reduced oxygen levels. The progression of these complications depends on the individual’s health, the type of surgery performed, and the body’s response to the surgical intervention. Monitoring and supportive care are essential to manage these complications effectively.

Trial ID:

2024-517373-25-00

Protocol code:

RACE_01

NCT ID:

NCT05492968

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Epinephrine, Norepinephrine, and Phenylephrine on Heart Function During Major Abdominal Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?