Study on the Effectiveness of Isoflurane, Propofol, and Midazolam for Sedation in Patients with Severe Brain Injuries

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What is this study about?

This clinical trial is focused on patients with severe brain conditions, known as neurocritical patients. These conditions can include serious brain injuries, strokes, or brain hemorrhages. The study is comparing two types of sedation methods used in these patients: one is a traditional method using medications given through a vein, known as intravenous sedation, and the other is a newer method using a gas called isoflurane that is inhaled. The purpose of the study is to evaluate how effective and safe the inhalation method is compared to the intravenous method.

During the study, patients will receive either the inhalation sedation with isoflurane or the conventional intravenous sedation, which may include medications like propofol or midazolam. The study will monitor various aspects of the patients’ sedation levels, such as how deeply they are sedated and how much medication is needed. It will also look at other health factors, including breathing, heart function, and any potential side effects. The study aims to see if the inhalation method can provide effective sedation while being safe for the patients.

The trial will also collect information on how long patients stay in the intensive care unit (ICU) and the hospital, as well as any changes in liver or kidney function. Additionally, the study will observe the patients’ recovery process, including how quickly they wake up and whether they experience confusion or delirium. This research hopes to provide valuable insights into the best sedation practices for patients with severe brain conditions.

1 joining the study

Upon joining the study, the patient must meet certain criteria: being 18 years or older, having a neurocritical condition such as intracranial hemorrhage or severe traumatic brain injury, and requiring advanced neurological monitoring and deep sedation.

A family member or legal representative must sign an informed consent form on behalf of the patient.

2 sedation method assignment

The patient will be assigned to one of two sedation methods: inhalation sedation using isoflurane or intravenous sedation using propofol or midazolam.

The method of sedation will be determined by the study protocol and the patient’s clinical needs.

3 sedation administration

For inhalation sedation, isoflurane will be administered through a device placed in the mouth or on the inspiratory branch. The concentration of isoflurane will be monitored, with an upper limit set at 1%.

For intravenous sedation, propofol or midazolam will be administered through a vein. The dosage will be adjusted based on the patient’s sedation needs.

4 monitoring and data collection

Throughout the study, various parameters will be monitored, including sedation levels using the RASS scale and Bispectral Index (BIS), respiratory and hemodynamic variables, and the patient’s infectious status.

The study will also track any adverse effects, the time it takes for the patient to wake up, and any changes in liver or kidney function.

5 study duration and follow-up

The study is expected to continue until February 16, 2026.

During this period, data will be collected on the number of days spent in the ICU and hospital, as well as mortality rates in both settings.

Who Can Join the Study?

Patients must be 18 years old or older.
Patients must be neurocritical, meaning they have serious brain conditions like intracranial hemorrhage (bleeding in the brain), severe traumatic brain injury (serious head injury), or stroke (a condition where blood flow to the brain is interrupted).
Patients must need advanced neurological monitoring, which involves special equipment to check brain activity, and deep sedation in an Intensive Care Unit (ICU).
A family member or legal representative must sign an informed consent form, which is a document that explains the study and confirms their agreement for the patient to participate.

Who Cannot Join the Study?

Patients who are not classified as neurocritical. This means patients who do not have severe brain or nervous system conditions requiring intensive care.
Patients who are not within the specified age range. The study is only for certain age groups, so if you are too young or too old, you may not be eligible.
Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care, such as those with certain disabilities or conditions.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	18.03.2024

Trial locations

Investigated drugs:

Propofol

Isoflurane is a medication used for inhalation sedation. In this clinical trial, it is being evaluated for its effectiveness and safety in sedating patients with severe neurological conditions. Isoflurane is administered through inhalation, allowing it to act quickly to help keep patients calm and comfortable during medical procedures.

Conventional Intravenous Sedation refers to the standard method of sedation where medications are given through a vein to help relax and sedate patients. This trial compares this traditional approach to the inhalation method using isoflurane, to see which is more effective and safer for patients with critical neurological conditions.

Neurocritical Patients – This term refers to individuals who are experiencing severe neurological conditions that require intensive medical care. These patients often have critical brain or spinal cord injuries, strokes, or other serious neurological disorders. The progression of their condition can involve changes in consciousness, motor function, and vital signs. They may require continuous monitoring and support for breathing, circulation, and other bodily functions. The condition of neurocritical patients can fluctuate, necessitating frequent assessments and adjustments in their care.

Trial ID:

2024-512077-27-00

Protocol code:

NEURO-CONDA

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Isoflurane, Propofol, and Midazolam for Sedation in Patients with Severe Brain Injuries

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?