This study evaluates the safety and effectiveness of Ciprofol, a new sedative, in critically ill patients receiving Extracorporeal Membrane Oxygenation (ECMO), a life-support system for heart or lung failure. The investigation aims to:
Assess how Ciprofol affects the oxygenator, a critical ECMO component responsible for adding oxygen to blood.
Compare the safety of Ciprofol to midazolam, a commonly used sedative. Eligibility Criteria Adults aged 18 years or older. Patients receiving ECMO and mechanical ventilation for over 72 hours. Individuals requiring sedation for medical procedures. Study Protocol
Participants will be randomly assigned to one of two groups:
Ciprofol Group: Initial sedation dose of 0.1 mg/kg, adjusted as needed. Midazolam Group: Initial sedation dose of 0.05 mg/kg, adjusted as needed. Both groups will receive pain management with remifentanil. Sedation levels will be adjusted daily by the clinical team to ensure patient safety and comfort.
Outcome Measures Primary: Oxygenator performance (oxygen and carbon dioxide levels) on Days 3 and 7.
Secondary: Changes in blood triglyceride and clotting marker (D-dimer) levels, oxygenator lifespan before replacement, and safety outcomes such as low blood pressure, respiratory issues, or allergic reactions.
Significance ECMO patients often require prolonged sedation, but current sedatives like midazolam may contribute to oxygenator damage. Ciprofol's potential for faster recovery and fewer side effects could improve sedation practices and device longevity in this high-risk population.
Receiving ECMO therapy with an anticipated duration exceeding 72 hours;
Requiring invasive mechanical ventilation;
Requiring sedation and analgesia treatment.
BMI >45 kg/m²;
Age <18 years;
Severe hepatic (Child-Pugh Class C) or renal failure (eGFR <15 mL/min/1.73m²);
History of severe psychiatric disorders;
Parallel
Ciprofol
DrugContinuous intravenous infusion (0.05-0.3 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Midazolam
DrugContinuous intravenous infusion (0.02-0.1 mg/kg/h), adjusted hourly based on the RASS score (target range: -3 to 0).
Composite Oxygenator Dysfunction
Definition: Meeting ≥2 of the following: Post-oxygenator PaO₂/FiO₂ \<200 mmHg ΔTransmembrane pressure (ΔdP) ≥20% from baseline or Transmembrane pressure (TMP)\>50 mmHg from baseline CO₂ clearance \<20% \[(Pre-MLCO₂ - Post-MLCO₂)/Pre-MLCO₂\] at gas flow ≥10 L/min
Oxygenator Transmembrane Pressure (TMP) Gradients
Transmembrane pressure (TMP) will be assessed using continuous inline pressure monitoring via the ECMO circuit's integrated pressure sensors (e.g., pre- and post-oxygenator pressure transducers). TMP is calculated as: TMP (mmHg) = Post-oxygenator Pressure - Pre-oxygenator Pressure
Post-oxygenator Oxygenation Index (PaO₂/FiO₂ Ratio)
The post-oxygenator PaO₂/FiO₂ ratio will be measured daily to evaluate oxygenator efficiency. A value \<200 mmHg indicates impaired oxygenation capacity.
Oxygenator Lifespan
Definition: Time (hours) from ECMO initiation to oxygenator replacement. Replacement Criteria: Meeting ≥2 composite dysfunction criteria.
Lipid Profile Changes
Measure: Serum triglycerides (TG)
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