A Phase 4 interventional study of Isoflurane and Propofol in Sedation and Airway Extubation, sponsored by Instituto de Investigación Hospital Universitario La Paz. Recruiting at 22 sites in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Phase 4, Interventional, and Treatment
The proposal of this study is to compare inhaled sedation with isoflurane administered via the Sedaconda ACD-S system with intravenous sedation with propofol. Patients will be randomized 1:1 to receive either inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous propofol. The primary endpoint is the number of ventilator-free days at 28 days after randomization.
Justification: Isoflurane has recently emerged as an attractive alternative for intensive care unit (ICU) sedation. Due to their favorable pharmaco-kinetic and dynamic profile, this agent has been progressively introduced into clinical practice. Isoflurane has proven to be non-inferior to propofol in terms of efficacy and safety and it has been suggested that it may facilitate ventilator weaning. However, no differences in length of mechanical ventilation were found. These studies have focused on short sedation durations. In fact, long-term effects and outcomes associated with isoflurane for ICU sedation are not yet fully understood.
Hypothesis: Inhaled sedation with isoflurane administered via the Sedaconda ACD-S system in critically ill patients leads to a shorter duration of mechanical ventilation at 28 days and a reduced length of ICU stay compared to intravenous sedation with propofol.
Main objective: To compare the number of ventilator-free days at day 28 post-randomization between critically ill patients receiving sedation with isoflurane versus those receiving intravenous sedation with propofol in critically ill patients expected to require more than 48 hours of invasive mechanical ventilation. Key secondary objective: To compare the number of ICU-free days at day 28 post-randomization in both treatment arms. Secondary objectives: To compare time to extubation after sedation withdrawal, efficacy in maintaining a target level of sedation, compare the percentage of patients requiring one or more additional hypnotics, compare the incidence and duration of delirium at day 28, assess mental, cognitive, and quality of life status at 90 days post-hospital discharge between both treatment groups.
Methodology: Phase IV, low-intervention, open-label, multicenter, randomized controlled trial with intention-to-treat analysis including mechanically ventilated patients expected to require a minimum of 48 hours of mechanical ventilation with a RASS score between -3 and -5. Patients will be randomized 1:1 to receive inhaled sedation with isoflurane administered via the Sedaconda ACD device (Sedana Medical, Uppsala, Sweden) or intravenous sedation with propofol. A total of 620 patients will be included from a pool of 22 participating centers.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 620 is above the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.
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- Adult patients receiving mechanical ventilation, with an anticipated duration >48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Inhaled sedation with Isoflurane. Initial dose: 3 mL/h. Gradual dose increase until target RASS is achieved. Do not exceed 14 mL/h. Guided by end tidal isoflurane concentration (EtISO), the recommended maximum dose for prolonged use is 1%. Short periods at up to 1.5% may be considered. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.
Drug: Isoflurane
Intravenous sedation with propofol (20 mg/mL). Initial dose: 0.5-1 mg/kg/h. Gradual dose increase until target RASS is achieved. Do not exceed 4 mg/kg/h. If the target RASS is not achieved at the maximum dose, a second hypnotic agent may be added.
Drug: Propofol
Inhaled sedation with isoflurane via Sedaconda ACD-S
Also known as: Inhaled sedation with Isoflurane
Intravenous sedation with Propofol 20 mg/ml
Also known as: Intravenous sedation with Propofol
Ventilator-free days at day 28 from randomization
Number of days between randomization and day 28 during which the patient is alive and free from invasive mechanical ventilation. Patients who die before day 28, or who remain on mechanical ventilation at day 28, are assigned zero ventilator-free days.
Time frame: From randomization until day 28
Key secondary objective: ICU-free days at day 28 post-randomization
Number of days between randomization and day 28 during which the patient is alive and free from the ICU. Patients who die before day 28, or remain in the ICU on day 28, are assigned zero ICU-free days.
Time frame: From randomization until day 28
Time to extubation
Mean number of hours from sedation withdrawal to successful extubation.
Time frame: From randomization until day 28
Administration of rescue sedation
Number of patients requiring the addition of one or more hypnotics
Time frame: From randomization until day 28
Sedation efficacy
Difference between the target sedation level and the actual measured level using Richmond Agitation Sedation Scale (RASS). Possible RASS score ranges from -5 (unarousable) to +4 (combative)
Time frame: From randomization until extubation or day 28
Number of Participants With Delirium
Number of patients with delirium using the Confusion Assessment Method in ICU (CAM-ICU)
Time frame: From randomization until extubation or day 28
Mortality
All cause mortality at 60 days from randomization
Time frame: From randomization to day 60
Number of Participants With Psychological disorders
Psychological status assessed using: 1.- Hospital Anxiety and Depression Scale (HADS). score of 8 or greater on the anxiety or depression subscale is used to identify symptoms of clinically significant anxiety or depression. 2.- Impact of Event Scale - Revised (IES-R), a self-report measure designed to assess the severity of post-traumatic stress disorder. Optimal screening threshold established as 1.6 (Consensus Conference on Prediction and Identification of Long-Term Impairments After Critical Illness. Crit Care Med 2020)
Time frame: at 90 days of hospital discharge
Number of Participants With Cognitive Disorders
Cognitive status assessed using Montreal Cognitive Assessment (MoCA) test. Total score ranges from zero to 30. Mild cognitive impairment: 18-25, moderate: 10-17, and severe: less than 10 (Consensus Conference on Prediction and Identification of Long-Term Impairments After Critical Illness. Crit Care Med 2020)
Time frame: at 90 days of hospital discharge
Number of Participants With Treatment-Related Adverse Events
Number of participants who experience at least one adverse event of special interest, deemed by the investigators to be related to the administered hypnotic, including events of mild, moderate, severe intensity, as well as serious adverse events
Time frame: From randomization to day 28
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Mar 2027, 15 months after the start.
Of 40 non-industry phase 4 interventional studies under Delirium, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 65. This study's planned 15 months is below that.
Counting every sponsor, half of 40 studies reached it within 44 months; a quarter within 25 and three quarters within 65.
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Studies of the drug tested here: Isoflurane
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