Inhaled Sedation in Critically Ill Patients
Key facts
- Who runs it
- Instituto de Investigación Hospital Universitario La Paz
- Where
- Spain22 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 620 people, planned
- Started
- 15 Dec 2025
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Isoflurane
- Propofol
- Record updated
- 29 June 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- Adult patients receiving mechanical ventilation, with an anticipated duration >48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5)
Who cannot take part
- Patients expected to require repeated surgical interventions during their ICU stay
- Allergy to isoflurane or propofol
- Acute neurological condition
- Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition
- Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales
- History of ventricular tachycardia or long QT syndrome
- Contraindication to isoflurane or propofol
- Patients with maternal ancestry from Venezuela, due to the potential presence of an mt-ND4 gene mutation associated with neurological injury after exposure to certain volatile anaesthetic agents
- Significant air leak, defined as a leak exceeding 30% of the delivered minute ventilation
- Cardiopulmonary arrest
- Tidal volume < 300 mL or PaCO₂ > 50 mmHg at the time of randomization
- Invasive mechanical ventilation for more than 48 hours at the time of randomization
- Pregnancy
- Breast feeding
- ECMO
- ECCO2R
- Active humidification strictly required
- Requirement for benzodiazepine use for a specific indication
- Burns
- Life expectancy less than 48 hours, or patients with such a level of severity that death during the ICU stay is considered highly likely
- Lack of informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Study groupTreatment being tested
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.
Treatment: Isoflurane
- Control groupExisting treatment, for comparison
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.
Treatment: Propofol
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- Official title
- Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial
- Fit questions
- Built from NCT07000526, who can take part
- Record updated
- 29 June 2026