Inhaled Sedation in Critically Ill Patients
Inhaled Sedation in Critically Ill Patients: a Multicentre Randomized Clinical Trial
Instituto de Investigación Hospital Universitario La Paz
620 participants
Dec 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- \- Adult patients receiving mechanical ventilation, with an anticipated duration \>48 hours after randomization, and requiring deep sedation (target RASS between -3 and -5).
Exclusion Criteria19
- Contraindication to isoflurane or propofol
- Allergy to isoflurane or propofol
- Cardiopulmonary arrest
- History of ventricular tachycardia or long QT syndrome
- 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
- Acute neurological condition
- Patients expected to require repeated surgical interventions during their ICU stay.
- ECMO
- ECCO2R
- Active humidification strictly required
- Neuromuscular disease or high spinal cord injury likely to prevent discontinuation of mechanical ventilation due to baseline condition
- 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.
- Any condition (e.g., blindness, deafness, dementia) or language barrier that prevents the administration of delirium or cognitive assessment scales.
- Lack of informed consent
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Interventions
Inhaled sedation with isoflurane via Sedaconda ACD-S
Intravenous sedation with Propofol 20 mg/ml
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT07000526