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Study on the Effects of Isoflurane and Propofol on Delirium in Intensive Care Patients on Mechanical Ventilation

Verified siteRegistered 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 in intensive care who are receiving invasive mechanical ventilation. The study is examining the effects of two different sedation strategies on the occurrence of delirium, a condition that can cause confusion and disorientation. The trial compares an inhaled sedation method using Isoflurane with a traditional intravenous sedation method. Isoflurane is administered through a special system called ANACONDA™. The purpose of the study is to determine which sedation strategy is more effective in reducing the frequency of delirium in these patients.

Participants in the study will receive either the inhaled Isoflurane or the intravenous sedation as part of their treatment while they are on mechanical ventilation. The study will monitor the occurrence of delirium and other outcomes such as the length of stay in intensive care, the need for additional medications, and the quality of sedation. The trial will also assess the impact on mortality rates and the number of days patients can live without mechanical ventilation.

In addition to Isoflurane, the study involves the use of other medications like Propofol and Sufentanil, which are commonly used for sedation and pain relief in intensive care settings. The trial aims to provide valuable insights into the best sedation practices for improving patient outcomes in intensive care units. The study is expected to continue until 2025, with recruitment starting in 2024.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Eligibility is confirmed for patients aged 18 and over who require mechanical ventilation for at least 24 hours and need continuous sedation for comfort and safety.

    Consent is obtained from the patient or a relative.

  2. Step 2

    Sedation strategy assignment

    Patients are assigned to one of two sedation strategies: inhaled sedation or intravenous sedation.

    The inhaled sedation strategy uses Isoflurane with an ANACONDA™-type system, starting from induction if intubated in the ICU or from admission if intubated pre-hospital.

    The intravenous sedation strategy involves medications such as Propofol and Sufentanil administered through injection or infusion.

  3. Step 3

    Sedation administration

    For inhaled sedation, Isoflurane is administered as an inhalation gas.

    For intravenous sedation, Propofol is given as an emulsion for injection or infusion, and Sufentanil is administered intravenously.

  4. Step 4

    Monitoring and assessment

    The primary focus is on the occurrence of delirium in the intensive care unit.

    Secondary assessments include ICU mortality, length of stay, days without mechanical ventilation, and the quality of sedation.

    Additional evaluations involve the need for extra medication or physical restraint, accidental removal of medical tubes, and self- or hetero-aggressive acts.

  5. Step 5

    Cognitive and psychological evaluation

    Cognitive consequences are assessed using CDR and IQCODE scores.

    Quality of life assessments are conducted at 3 and 12 months post-trial.

  6. Step 6

    Trial duration

    The trial is expected to end by August 6, 2025.

    Recruitment for the trial is estimated to start on August 30, 2024.

Who can join the trial?

4 criteria

  • Patient aged 18 and over
  • Patient requires mechanical ventilation for at least 24 hours. This means the patient needs a machine to help them breathe.
  • Patient requires immediate continuous sedation for comfort, safety, and to help with life-saving treatments. Sedation means using medicine to make the patient calm or sleepy.
  • Consent obtained from patient or relative. This means the patient or their family member agrees to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might have special needs or circumstances that require extra protection.
  • Patients who have medical conditions or factors that the study has not specifically mentioned as being included.
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Investigated drugs

  • Isoflurane

    is a medication used for inhaled sedation. In this study, it is administered to patients who are on mechanical ventilation in the intensive care unit. The goal is to see if using Isoflurane can reduce the occurrence of delirium compared to other sedation methods. It is delivered through a special system called ANACONDA™, which allows the medication to be inhaled directly into the lungs.

  • Intravenous Sedation

    refers to the traditional method of providing sedation through a vein. This approach is commonly used in intensive care settings for patients who require mechanical ventilation. The study compares this method to the inhaled sedation strategy to determine which is more effective in preventing delirium.

What is already known about the treatment

Isoflurane – Isoflurane is administered through inhalation using an ANACONDA™-type system, primarily in intensive care settings for patients requiring mechanical ventilation. It is currently being studied for its effects on reducing the frequency of delirium in such patients. The main therapeutic indication for Isoflurane in this context is sedation. At the molecular level, Isoflurane works by enhancing the activity of inhibitory neurotransmitters in the brain, leading to a calming effect. It is classified as a general anesthetic.

Investigated diseases

Delirium – Delirium is a sudden change in a person's mental state, characterized by confusion, disorientation, and difficulty focusing attention. It often occurs in hospital settings, especially in intensive care units, and can fluctuate in severity throughout the day. Patients may experience hallucinations, restlessness, or agitation, and their ability to think clearly is impaired. The condition can develop quickly, often within hours or days, and is usually triggered by an underlying medical issue, such as an infection or medication side effects. Delirium is more common in older adults and those with pre-existing cognitive impairments. It is important to identify and address the underlying causes to help manage the symptoms effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513530-37-00Protocol code29BRC19.0280Estimated enrolment250 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

sourced from the EU Clinical Trials Register and site verification

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