Study Comparing Isoflurane and Propofol for Sedation in Critically Ill Patients on Mechanical Ventilation

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What is this study about?

This clinical trial is focused on patients who are critically ill and require mechanical ventilation, which is a machine that helps them breathe. The study is comparing two types of sedation, which is a way to help patients stay calm and comfortable while on the ventilator. One group of patients will receive sedation through inhalation using a medication called Isoflurane, while the other group will receive sedation through an intravenous method using a medication called Propofol. Both medications are commonly used to help patients relax and are administered in different ways.

The purpose of the study is to see which sedation method allows patients to be free from mechanical ventilation for more days within a 28-day period. Patients in this study are expected to need mechanical ventilation for more than 48 hours. The study will also look at other factors, such as the number of days patients spend in the intensive care unit (ICU), the time it takes for patients to be taken off the ventilator after stopping sedation, and the overall well-being of patients after they leave the hospital.

Throughout the study, researchers will monitor various aspects of the patients’ health, including their mental state using a scale called the RASS (Richmond Agitation-Sedation Scale), and check for any signs of delirium, which is a state of confusion. They will also assess if patients experience anxiety, depression, or post-traumatic stress disorder after their hospital stay. The study aims to provide valuable information on the best sedation practices for critically ill patients who need mechanical ventilation.

1 randomization

Upon joining the study, randomization occurs to determine the sedation method. This involves assigning either isoflurane for inhalation or propofol for intravenous use.

The goal is to compare the effectiveness of these two sedation methods in critically ill patients.

2 sedation administration

If assigned to the isoflurane group, sedation is administered through inhalation using a liquid form that turns into vapor.

If assigned to the propofol group, sedation is administered intravenously as an emulsion for injection or infusion.

Sedation is maintained to achieve a RASS (Richmond Agitation-Sedation Scale) score between -3 and -5, indicating a deep level of sedation.

3 mechanical ventilation

Participants are expected to be on mechanical ventilation for at least 48 hours from the time of randomization.

The primary objective is to assess the number of days free from mechanical ventilation by day 28.

4 monitoring and assessment

Throughout the trial, various parameters are monitored, including the average RASS score during sedation, the need for additional hypnotics, and the presence of delirium.

Assessments also include the time until extubation after sedation withdrawal and the number of days free from ICU stay by day 28.

5 follow-up evaluations

Participants are evaluated for symptoms of anxiety, depression, or post-traumatic stress disorder 90 days after hospital discharge.

Cognitive assessments are conducted 90 days post-discharge to identify any abnormal scores.

The occurrence of any adverse reactions is recorded for both treatment groups.

6 trial completion

The trial is expected to conclude by December 31, 2027.

The final analysis will include the proportion of participants who died from any cause by day 60 and other secondary endpoints.

Who Can Join the Study?

Must be 18 years old or older.
Must be on a breathing machine (mechanical ventilation) and expected to need it for at least 48 hours.
Must need to maintain a RASS (Richmond Agitation-Sedation Scale) score between -3 and -5. This scale measures how awake or sleepy a person is, with these numbers indicating a deep level of sedation.

Who Cannot Join the Study?

Patients who are not in a critical condition cannot participate. A critical condition means the patient is very seriously ill and needs intensive medical care.
Patients who are not expected to need more than 48 hours of invasive mechanical ventilation cannot participate. Invasive mechanical ventilation is when a machine helps a patient breathe through a tube placed in their windpipe.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients can participate, but those who do not meet other criteria cannot join.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario Puerta De Hierro De Majadahonda	Majadahonda	Spain
Hospital Universitario De Getafe	Getafe	Spain
Hospital Universitario Rio Hortega	Valladolid	Spain
Hospital Universitario Infanta Leonor	Madrid	Spain
Hospital Universitari Joan XXIII De Tarragona	Tarragona	Spain
Hospital Universitario De Fuenlabrada	Fuenlabrada	Spain
Hospital General Universitario De Albacete	Albacete	Spain
Hospital Universitario Rey Juan Carlos	Mostoles	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida	Lleida	Spain
Hospital De Galdakao Usansolo	Galdakao	Spain
Hospital Santa María	Lleida	Spain
Himpakce Uwtfvowmkeqzt Dx Li Pnrufwyj	Madrid	Spain
Pvos Tzbzi Hfnmdpsb Ulrkajmojeog	Sabadell	Spain
Fpvkmqptc Pylx Ly Itucruvgdzpkn Bbyrquwwh Dss Hdhnkfjy Ukouprnbxbtlf Lm Pvr	Madrid	Spain
Hjkqxues Umapvnldvezty Hihrxsst Tygun y Pyctni Iibeomth Cgqabc dflkabxydbhidkdjm (ggvn	Badalona	Spain
Hrpdcgjt Vamb durgdmee	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.05.2025

Trial locations

Investigated drugs:

Isoflurane is a medication used for sedation in critically ill patients. It is administered through inhalation and helps to keep patients calm and comfortable while they are on mechanical ventilation. This medication is often used in hospital settings, especially in intensive care units, to manage sedation for patients who need assistance with breathing for extended periods.

Propofol is another medication used for sedation, but it is given intravenously. It is commonly used to sedate patients who are on mechanical ventilation. Propofol helps to ensure that patients remain relaxed and pain-free during their treatment in the intensive care unit. It is known for its quick onset and ability to be easily adjusted to the needs of the patient.

Investigated diseases:

Critical illness

Critical condition – A critical condition refers to a state where a patient is experiencing severe health issues that require immediate and intensive medical care. This condition often involves life-support measures, such as mechanical ventilation, to maintain vital functions. Patients in a critical condition may be unable to breathe on their own and require sedation to manage pain and anxiety. The progression of a critical condition can vary widely, depending on the underlying cause and the patient’s response to treatment. It is characterized by instability in vital signs and requires constant monitoring and intervention.

Trial ID:

2024-518521-14-00

Protocol code:

SI-CRITIC

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Isoflurane and Propofol for Sedation in Critically Ill Patients on Mechanical Ventilation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?