Acute Lung Injury and Acute Respiratory Distress Syndrome
Conditions
Interventions
Midazolam group:24 mL normal saline + 30 mg midazolam administered by intravenous infusion (0.02–0.1 mg/kg/h
a loading dose of 0.01–0.05 mg/kg may be given if required), together with either:
47 mL normal saline + 150 µg sufentanil citrate injection by intravenous infusion (0.2–0.3 µg/kg/h
loading dose 0.2–0.5 µg/kg if required), OR
50 mL normal saline + 2 mg remifentanil hydrochloride for injection by intravenous infusion (0.15–0.2 µg/kg/min
loading dose 0.5–1.0 µg/kg if required).
Remimazolam group:50 mL normal saline + 72 mg remimazolam administered by intravenous infusion (0.1–0.4 mg/kg/h
a loading dose of 0.1–0.2 mg/kg may be given if required), together with either:
47 mL normal saline + 150 µg sufentanil citrate injection by intravenous infusion (0.2–0.3 µg/kg/h
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age > 18 years 2. Fulfillment of the diagnostic criteria in the 2023 Global Updated Definition of ARDS 3. Anticipated requirement for invasive mechanical ventilation = 48 h 4. Signed informed consent obtained from the patient or legal surrogate
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Known hypersensitivity to remimazolam, midazolam, sufentanil, or remifentanil. 3. Active malignancy. 4. Participation in another clinical trial within the preceding 3 months. 5. Death expected within 48 hours. 6. Severe acute or chronic neuromuscular disease, or any condition that precludes reliable RASS assessment. 7. Acute hepatitis or severe hepatic dysfunction (Child-Pugh class C). 8. Chronic kidney disease with eGFR 25 % from baseline OR SBP 3 µg/kg/h without response. 11. Severe ARDS requiring ECMO support. 12. Advanced pulmonary fibrosis or other irreversible severe lung disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the number of ventilator-free days at days 7 and 28.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 28-day mortality;Plateau pressure, driving pressure, static compliance, airway resistance, PEEPi, and P0.1 after sedoanalgesia in both groups.; | — |
Countries
China
Contacts
Public ContactZhang Yuanli
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed