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Opioid-Free Analgesia In Intensive Care Unit : A Prospective, Monocentric, Randomized, Double-Blind, Feasibility Clinical Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517770-14-00
Acronym
LOCAL/2022/RW-01
Enrollment
50
Registered
2024-10-17
Start date
2025-11-24
Completion date
Unknown
Last updated
2025-11-19

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

Conditions

Intubation

Brief summary

daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation

Detailed description

Cumulative dose of remifentanil, Number of lived days free of remifentanil, Daily consumption of sedative drugs from inclusion to D28, Number of live days free of mechanical ventilation, SOFA Score (Sepsis-related Organ Failure Assessment), Daily fuid intake in milliliter, CAM ICU test, Presence of one or more events of special interest or expected adverse events: constipation, bradycardia, bladder globe, nausea, vomiting, liver disturbance, serotonin syndrome, Presence of pneumonia associated with mechanical ventilation, Extubation failure and cause (reintubation within 48 hours of first extubation), Length of stay in the intensive care unit and in the hospital, Vital status at day 28 and day 90, Opioid use at D90

Interventions

Sponsors

Centre Hospitalier Universitaire De Nimes
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
daily consumption of remifentanil between the 24th hour and the 48th hour after randomisation of patients admitted to the ICU and requiring at least 72 hours of mechanical ventilation

Secondary

MeasureTime frame
Cumulative dose of remifentanil, Number of lived days free of remifentanil, Daily consumption of sedative drugs from inclusion to D28, Number of live days free of mechanical ventilation, SOFA Score (Sepsis-related Organ Failure Assessment), Daily fuid intake in milliliter, CAM ICU test, Presence of one or more events of special interest or expected adverse events: constipation, bradycardia, bladder globe, nausea, vomiting, liver disturbance, serotonin syndrome, Presence of pneumonia associated with mechanical ventilation, Extubation failure and cause (reintubation within 48 hours of first extubation), Length of stay in the intensive care unit and in the hospital, Vital status at day 28 and day 90, Opioid use at D90

Countries

France

Outcome results

None listed

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