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Study on Sevoflurane and Propofol for Heart Protection in Double Valve Surgery Patients

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on patients undergoing double valve surgery, a procedure involving the replacement or repair of two heart valves. The study aims to compare the effects of two medications, Sevoflurane and Propofol, during and after the surgery. Sevoflurane is commonly used as an anesthetic gas, while Propofol is an injectable anesthetic. The purpose of the study is to evaluate how these medications affect heart and kidney protection during the surgery, particularly in reducing heart muscle damage and injury.

During the trial, patients will receive either Sevoflurane or Propofol while undergoing surgery. The study will monitor various health indicators, such as heart function and kidney health, by measuring specific proteins and enzymes in the blood. These include NT-ProBNP and Troponin I, which are markers of heart stress and damage. The trial will also assess the need for medications that support heart function if the heart's output is low after surgery.

The study will take place over a period of time, with patients being observed both during the surgery and in the recovery phase. The goal is to determine which medication provides better protection for the heart and kidneys, potentially leading to improved outcomes for patients undergoing this type of heart surgery. The trial is expected to conclude by May 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as being 18 years or older and scheduled for elective double valve cardiac surgery.

    The use of Nido cardioplegia, a method to protect the heart during surgery, is common in this type of patient.

  2. Step 2

    Pre-surgery preparation

    Before surgery, baseline measurements are taken, including cardiac index, creatinine levels, and other relevant health indicators.

    These measurements help in assessing the effects of the medications used during the trial.

  3. Step 3

    Surgery and medication administration

    During the surgery, the effects of sevoflurane and propofol are compared. Propofol is administered as an intravenous infusion at a concentration of 10 mg/ml.

    The goal is to evaluate the reduction of heart damage and injury by measuring levels of specific proteins and cardiac function.

  4. Step 4

    Post-surgery monitoring

    After surgery, continuous monitoring of heart function and other health indicators is conducted.

    Measurements include cardiac index, heart rate, and levels of proteins that indicate heart and kidney function.

  5. Step 5

    Follow-up and data collection

    Data on various health parameters are collected, including the duration of stay in the intensive care unit and the need for medications that support heart function.

    The study aims to complete data collection by May 30, 2025.

Who can join the trial?

5 criteria

  • Must be **18 years or older**.
  • Scheduled for **elective cardiac surgery** involving **double valve replacement**. This means the surgery is planned in advance and involves replacing two heart valves.
  • Use of **Nido cardioplegia** during surgery. This is a special solution used to protect the heart during surgery.
  • Both **male and female** participants are eligible.
  • Participants should not belong to a **vulnerable population**. This means they should not be in a group that needs special protection, like children or people unable to make decisions for themselves.

Who cannot join the trial?

7 criteria

  • Patients who are not undergoing double valve surgery.
  • Patients who are not receiving sevoflurane or propofol during their surgery.
  • Patients who are not having their heart function measured during and after surgery.
  • Patients who are not having their heart damage markers, like NT-ProBNP and troponin I, measured. These are substances in the blood that can show if the heart is damaged.
  • Patients who are not using inotropes for low cardiac output syndrome. Inotropes are medicines that help the heart pump better.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need extra protection in a study.
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Investigated drugs

  • Sevoflurane

    is an inhaled anesthetic used during surgeries to help patients remain unconscious and pain-free. In this trial, it is being studied for its potential protective effects on the heart and kidneys during and after double valve surgery. Researchers are interested in how sevoflurane might reduce heart damage and improve heart function during the surgery and recovery period.

  • Propofol

    is an intravenous anesthetic commonly used to induce and maintain anesthesia during surgeries. In this trial, it serves as a comparison to sevoflurane to evaluate which anesthetic provides better protection for the heart during double valve surgery. The study aims to see if propofol is less effective, equally effective, or more effective than sevoflurane in reducing heart damage and supporting heart function.

What is already known about the treatment

  • Sevoflurane

    Sevoflurane is administered as an inhaled anesthetic, typically used during surgeries to maintain sedation. It is currently well-established in medical practice and literature as a safe and effective anesthetic agent. The main therapeutic indication for sevoflurane in this trial is to evaluate its cardioprotective and nephroprotective effects during and after double valve surgery. At the molecular level, sevoflurane works by enhancing the activity of inhibitory neurotransmitters in the brain, leading to a decrease in neuronal activity and resulting in sedation. It is classified pharmacologically as a volatile anesthetic agent.

  • Propofol

    Propofol is administered intravenously and is commonly used for the induction and maintenance of anesthesia. It is widely recognized in medical literature as a fast-acting sedative with a short duration of action. In this trial, propofol is used as a comparator to assess its effects on myocardial damage and injury during double valve surgery. Propofol works by enhancing the inhibitory effects of the neurotransmitter GABA in the brain, leading to sedation. It is classified as a general anesthetic.

Investigated diseases

Myocardial Damage – This condition involves injury to the heart muscle, often resulting from reduced blood flow or oxygen supply. It can occur during surgical procedures, such as double valve surgery, especially when the heart is temporarily stopped. The damage is typically assessed by measuring specific biomarkers like NT-ProBNP and troponin I. These markers indicate the extent of injury to the heart tissue. The condition can affect the heart's ability to pump effectively, leading to complications such as low cardiac output syndrome. Monitoring and managing myocardial damage is crucial during and after surgery to ensure proper heart function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-520812-33-00Estimated enrolment70 patientsSponsorFundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud

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