Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT04790734
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 75 years;
* Intubated and mechanically ventilated ≤96 hours before enrollment；
* Expected to require continuous invasive ventilation and sedation ≥24 hours;
* Requirement for light to moderate sedation (a RASS score of -3 to 0).
Exclusion Criteria:
* Body mass index (BMI) \<18 or \>30 kg/m2;
* Acute severe neurological disorder and any other condition interfering with RASS assessment;
* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
* Heart rate less than 50 beats/min;
* Second- or third-degree heart block in the absence of a pacemaker;
* Unstable angina;
* Acute myocardial infarction;
* Left ventricular ejection fraction less than 30%;
* Contraindicate or allergic to study drugs;
* Moribund state;
* Acute hepatitis or serious hepatic dysfunction (Child-Pugh class C);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 60 ml/min/1.73m2;
* Alcohol abuse;
* Myasthenia gravis;
* Pregnancy or lactation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04790734
Study Brief:
Protocol Section:
NCT04790734