AuthorisedTherapeutic use (Phase IV)Interventional

The effect of epinephrine, norepinephrine and phenylephrine on intraoperative hemodynamic performance – a prospective double-blinded randomized clinical trial

This research is looking at how three common medicines — epinephrine, norepinephrine, and phenylephrine — affect heart function during major operations on the tummy. These medicines are often used during surgery to help keep blood pressure steady and ensure enough blood reaches important organs. The study aims to find out which of these medicines is best at maintaining a strong and stable heart output (how much blood the heart pumps) throughout the surgery. They also want to see how these medicines affect oxygen levels in the brain and other body tissues. This information will help doctors choose the most effective medicine for patients undergoing this type of surgery.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Medical University Of Vienna

Enrolment target

225

Start

14 Oct 2024

Patients undergoing open major abdominal surgery

What is this study about?

This study is a research project designed to look closely at how certain medications affect your body during major tummy surgery. When you have a big operation, doctors sometimes use medicines like epinephrine, norepinephrine, and phenylephrine to help keep your blood pressure stable and ensure your heart is pumping blood effectively. These medicines are already widely used in hospitals.

The main goal of this study is to compare these three medicines directly. Researchers want to understand which one is best at keeping your heart's blood pumping action (called cardiac output) steady and strong throughout the entire surgery. They'll be carefully monitoring this to see if one medicine performs better than the others.

Beyond simply checking heart function, the study will also look at how much oxygen is reaching your brain and other parts of your body during surgery. This is important because good oxygen supply is vital for healthy healing and recovery. By comparing these aspects, doctors hope to gain a clearer picture of which medicine provides the most support during major operations, ultimately helping them make better choices for future patients.

Key takeaways

Compares three standard medicines used during major tummy surgery.
Aims to find the best medicine for stable heart function and oxygen levels.
Participants will receive one of these medicines as part of their surgery.
Close monitoring of heart and oxygen levels will happen during the operation.
The study helps doctors improve care for future patients undergoing similar surgery.

Who may be eligible?

This study is looking for adult patients who are going to have major surgery on their tummy. This means the operation will be quite significant and will involve open surgery, rather than keyhole surgery.

There are no specific age limits beyond being an adult (18 years or older), and the study is open to both men and women. The specific type of surgery is the main factor the researchers are interested in.

To find out if you might be suitable, the research team will check if your planned surgery fits what they are looking for and if you meet any other health criteria they have to ensure the study is safe for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you having a planned major operation on your tummy?
Is your surgery an 'open' surgery (not keyhole)?
Are you generally suitable for such an operation?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will already be scheduled for major tummy surgery. The main difference will be that during your operation, one of the three study medicines (epinephrine, norepinephrine, or phenylephrine) will be given to you as a continuous drip, which is a standard part of care for this type of surgery anyway. You won't know which specific medicine you are receiving, and neither will your doctors during the operation – this helps make the study fair and unbiased.

The research team will simply be carefully monitoring your heart's activity, blood pressure, and oxygen levels in your brain and tissues throughout your surgery, using equipment that is commonly used in operating theatres. There will be no extra procedures specifically for the study. After your surgery, the researchers will continue to collect information from your usual hospital records about how you recover. The total duration of your participation would effectively cover your time in surgery and your hospital stay for recovery, though specific follow-up times will be explained by the study team.

Potential risks and benefits

Taking part in this study means you'll receive one of three medicines that are already routinely used to support patients during major surgery. There's a chance that comparing these drugs could help doctors understand how to give better care in the future. As with any medical procedure or medication, there are always potential risks, though these medicines are well-known and their effects are carefully managed by your anaesthetist. You will be closely monitored throughout your surgery regardless of whether you are in this study. You are free to withdraw from the study at any time without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Austria

Common questions

What kind of surgery is this study for?

This study is for people having big, open operations on their tummy.

What medicines are being studied?

The study compares three commonly used medicines: epinephrine, norepinephrine, and phenylephrine, all given by a drip.

Will I know which medicine I'm getting?

No, neither you nor your doctors will know, to keep the study fair. This is called 'double-blind'.

What will happen to me during the study?

During your surgery, doctors will carefully monitor your heart, blood pressure, and oxygen levels, which is similar to routine care.

Who can take part?

Adults (18 years or older) scheduled for major open abdominal surgery can take part, regardless of gender.