All studies
AuthorisedPhase II and Phase III (Integrated)Interventional

CARDIOPROTECTIVE-NEPHROPROTECTIVE EFFECTS OF SEVOFLURANE IN COMPARISON WITH PROPOFOL IN DOUBLE VALVE SURGERY. USE OF SEVOFLURANE AS A PILLAR OF PROTECTION IN EXTRACORPOREAL CIRCULATION AND POSTOPERATIVE SEDATION

This research is looking at patients who are having double heart valve replacement surgery. We want to see if one type of anaesthetic, called sevoflurane, offers more protection to your heart and kidneys during and after the operation compared to another common anaesthetic, propofol. We will measure specific markers in your blood to check for any heart damage and how well your heart is working. We will also look at your kidney function and how long you might need to stay in intensive care. The aim is to find out which anaesthetic might lead to a better and smoother recovery for patients undergoing this type of surgery.

At a glance

Status
Authorised
Phase
Phase II and Phase III (Integrated)
Sponsor
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud
Enrolment target
70
Start
27 Jan 2025

What is this study about?

Imagine you're having a big heart operation, like replacing two heart valves. During this surgery, doctors use anaesthetics to make sure you're asleep and comfortable. This study is like a careful comparison between two common anaesthetics: one called sevoflurane and another called propofol.

The main idea is to see if one of these anaesthetics does a better job of protecting your heart and kidneys throughout the surgery and during your initial recovery. During heart surgery, especially when a heart-lung machine is used, your body goes through a lot. We want to understand if sevoflurane can act as a kind of shield, helping to reduce any stress or damage to your heart muscle and kidneys, compared to propofol.

To figure this out, doctors will be looking at several things. They'll measure special markers in your blood that can show if your heart has been a bit stressed or damaged. They'll also check how well your heart is pumping blood around your body and how well your kidneys are working. By carefully comparing these measurements between patients who receive sevoflurane and those who receive propofol, the researchers hope to learn which anaesthetic strategy might be more helpful for patients facing this procedure.

Key takeaways

  • This study compares two common anaesthetics during heart valve surgery.
  • It aims to see which anaesthetic better protects the heart and kidneys.
  • Researchers will monitor heart function and recovery closely.
  • Participants must be adults having double heart valve surgery.
  • Both men and women can join.
  • Results could improve future care for patients.

Who may be eligible?

To take part in this study, you must be an adult aged 18 or older. There is no upper age limit, meaning older adults are also welcome to participate.

This study is specifically for people who are scheduled to have double heart valve surgery. This means you will be having two valves in your heart repaired or replaced during the same operation.

Both men and women are welcome to participate in this study. The researchers want to include a wide range of patients to ensure the results are as widely applicable as possible.

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.

  1. Are you 18 years old or older?
  2. Are you scheduled to have two heart valves operated on at the same time?
  3. Are you feeling well enough to consider taking part in research?
  4. Are you able to understand and provide consent for the study procedures?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive either sevoflurane or propofol as your anaesthetic during and shortly after your double heart valve surgery, as decided by the study team. Both are standard anaesthetics used in surgery.

Throughout your hospital stay, especially during and after the operation, doctors and nurses would take additional blood and urine samples and measure your heart's function more closely than usual. This includes monitoring your heart rate, blood pressure, and how well your heart is pumping (cardiac index).

They will pay close attention to your recovery in the intensive care unit (ICU), including how long you stay there and whether you need medicines to help your heart pump. The total duration of your participation would cover your hospital stay related to the surgery and immediate recovery.

Potential risks and benefits

Taking part could help us understand which anaesthetic is best for protecting the heart and kidneys during valve surgery, potentially leading to better care for future patients. There are no direct benefits to you beyond the standard high-quality care you would receive for your surgery. Every medication has potential side effects, and both sevoflurane and propofol are common anaesthetics with known safety profiles. Any risks associated with the specific anaesthetic you receive will be fully explained by your doctor. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (1)

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

Common questions

What is 'double valve surgery'?

Double valve surgery means you are having two of your heart valves repaired or replaced in the same operation.

What's the difference between sevoflurane and propofol?

Both are medicines used to make you unconscious during surgery. This study is comparing them to see if one offers better protection to your heart and kidneys.

Will I know which anaesthetic I'm getting?

No, in this type of study, patients generally don't know which anaesthetic they are receiving. This helps make sure the results are fair and unbiased.

Are these anaesthetics commonly used?

Yes, both sevoflurane and propofol are widely used and well-understood anaesthetics in hospitals for various surgeries.

What are 'NT-ProBNP' and 'troponin I'?

These are natural substances in your blood. Doctors measure their levels to check for any stress or damage to your heart muscle.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.