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Study on Sedation During Transcatheter Aortic Valve Replacement in Patients with Aortic Stenosis Using Remifentanil, Dexmedetomidine, and Propofol

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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 studying the effects of different medications used for sedation during a procedure called Transcatheter Aortic Valve Replacement (TAVR). TAVR is a treatment for patients with aortic stenosis, a condition where the heart's aortic valve becomes narrowed, affecting blood flow. The medications being studied include Remifentanil, Dexmedetomidine, Propofol, and Ketamine. These medications are used to help patients relax and feel comfortable during the procedure.

The purpose of the study is to determine if there are differences in the occurrence of certain conditions during and after the procedure, such as respiratory acidosis and emergence delirium. Respiratory acidosis is a condition where there is too much carbon dioxide in the blood, and emergence delirium is a state of confusion that can occur after waking up from sedation. The study will compare how often these conditions occur with each medication.

Participants in the study will receive one of the medications during their TAVR procedure. The study will monitor their condition during the procedure and for 24 hours afterward to check for any signs of respiratory acidosis or emergence delirium. The study aims to provide valuable information on the safety and effectiveness of these sedation medications during TAVR procedures.

The research process

The trial runs in 8 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, the patient will undergo a process to confirm eligibility. This includes verifying age between 18 and 95 years and confirming the patient's agreement to participate by signing an informed consent form.

  2. Step 2

    Preparation for TAVR procedure

    The patient will be prepared for the Transcatheter Aortic Valve Replacement (TAVR) procedure. This involves ensuring the patient is ready for sedation and the procedure itself.

  3. Step 3

    Sedation administration

    During the procedure, the patient will receive sedation through infusion. The medications used include remifentanil, propofol, and ketamine hydrochloride. These are administered as solutions for injection or infusion to maintain the desired level of sedation.

  4. Step 4

    Monitoring during procedure

    Throughout the procedure, the patient's vital signs and sedation levels will be closely monitored. The goal is to achieve a specific sedation target and ensure the patient's safety.

  5. Step 5

    Post-procedure observation

    After the procedure, the patient will be observed for any immediate effects of the sedation. This includes monitoring for respiratory acidosis and emergence delirium within the first 24 hours.

  6. Step 6

    Assessment of sedation effectiveness

    The effectiveness of the sedation will be assessed by measuring the time taken to reach the desired sedation level and the time to meet discharge criteria from the operating room.

  7. Step 7

    Evaluation of adverse events

    The study will evaluate any adverse events that occur during and after the procedure. This includes respiratory and hemodynamic events during the procedure, as well as cognitive changes post-operation.

  8. Step 8

    Follow-up and conclusion

    The patient's recovery and any long-term effects will be monitored until the conclusion of the study, which is estimated to end by July 1, 2026.

Who can join the trial?

3 criteria

  • Patients who are having a procedure called Transcatheter Aortic Valve Replacement (TAVR). This is a treatment for a heart condition known as aortic stenosis, where the valve in the heart becomes narrow.
  • Patients must be between the ages of 18 and 95 years old.
  • Patients must agree to take part in the study and sign a document called an informed consent form, which explains the study and confirms their willingness to participate.

Who cannot join the trial?

4 criteria

  • Patients who have not undergone a procedure called transcatheter aortic valve replacement for a condition known as aortic stenosis cannot participate. This procedure involves replacing a heart valve without open-heart surgery.
  • Individuals who are not within the specified age range for the study are excluded. The study is looking for participants in certain age groups.
  • Both males and females are eligible, but if someone does not identify as either, they may not be able to participate.
  • People who are considered part of a vulnerable population are not included. This term refers to groups who might need special protection, like children or those unable to give consent.
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Investigated drugs

  • Propofol

    is a medication used to help patients relax or sleep during medical procedures. In this trial, it is used to provide sedation to patients undergoing Transcatheter Aortic Valve Replacement (TAVR). The goal is to see if it affects the patient's breathing or causes confusion after the procedure.

  • Dexmedetomidine

    is another sedative used in this trial. It helps to calm patients and can also provide pain relief. The study aims to compare its effects on breathing and mental clarity after the TAVR procedure with those of other sedatives.

  • Midazolam

    is a medication that helps patients feel relaxed or sleepy before and during medical procedures. In this trial, it is used to see how it affects breathing and mental state after the TAVR procedure compared to other sedatives.

What is already known about the treatment

Propofol – Propofol is administered intravenously and is commonly used for sedation during medical procedures. It is well-established in medical practice and literature as a sedative and anesthetic agent. The main therapeutic indication for Propofol is to induce and maintain sedation or anesthesia. At the molecular level, Propofol works by enhancing the activity of the neurotransmitter GABA, which inhibits brain activity, leading to sedation. It is classified pharmacologically as a general anesthetic.

Investigated diseases

Aortic Stenosis – Aortic stenosis is a condition where the aortic valve in the heart becomes narrowed, restricting blood flow from the heart to the rest of the body. This narrowing can lead to increased pressure within the heart, causing the heart muscle to thicken and potentially weaken over time. As the condition progresses, individuals may experience symptoms such as chest pain, fatigue, shortness of breath, and fainting, especially during physical activity. The severity of symptoms often correlates with the degree of valve narrowing. Over time, the heart's ability to pump blood effectively may diminish, leading to further complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511018-18-00Estimated enrolment1 patientSponsorAzienda Socio Sanitaria Territoriale Ovest Milanese

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