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Inhaled sedation in the critically ill patient: a multicentre randomised clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518521-14-00
Acronym
SI-CRITIC
Enrollment
620
Registered
2025-03-14
Start date
2025-10-17
Completion date
Unknown
Last updated
2025-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical condition

Brief summary

Mean number of days free of mechanical ventilation at day 28 from randomization.

Detailed description

Mean number of days free of ICU stay on day 28 from randomization., Average number of hours until extubation after withdrawal of sedation evaluated on the day of withdrawal or on day 28, whichever occurs first, from randomization., Average RASS scale score maintained during the sedation maintenance period by participants in both treatment arms., Proportion of participants that require the additon one or more hypnotics., Proportion of participants with delirium on day 28 and average number of days with delirium on day 28 (assessed using the CAM-ICU scale)., Proportion of participants who died from any cause until day 60 from randomization., Proportion of participants with symptoms of anxiety, depression or post-traumatic stress disorder 90 days after hospital discharge., Proportion of patients who present an abnormal score in the cognitive assessment 90 days after hospital discharge., Proportion of patients presenting adverse reactions in both arms., Average number of hours to awakening (RASS range from -1 to +1) after sedation withdrawal., Proportion of patients with abnormal scores on functional activity assessment (Barthel Index) at 90 days after hospital discharge.

Interventions

DRUGPropofol Fresenius 20 mg/ml emulsión para inyección o perfusión
DRUGSedaconda 100% líquido para inhalación del vapor

Sponsors

Hospital Universitario La Paz
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Mean number of days free of mechanical ventilation at day 28 from randomization.

Secondary

MeasureTime frame
Mean number of days free of ICU stay on day 28 from randomization., Average number of hours until extubation after withdrawal of sedation evaluated on the day of withdrawal or on day 28, whichever occurs first, from randomization., Average RASS scale score maintained during the sedation maintenance period by participants in both treatment arms., Proportion of participants that require the additon one or more hypnotics., Proportion of participants with delirium on day 28 and average number of days with delirium on day 28 (assessed using the CAM-ICU scale)., Proportion of participants who died from any cause until day 60 from randomization., Proportion of participants with symptoms of anxiety, depression or post-traumatic stress disorder 90 days after hospital discharge., Proportion of patients who present an abnormal score in the cognitive assessment 90 days after hospital discharge., Proportion of patients presenting adverse reactions in both arms., Average number of hours to awakening

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026