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 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 12:44 AM
NCT ID:
NCT05555667
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 and ≤ 80 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;
* Allergy or unsuitabilty to any composition of study drugs or remifentanil;
* Living expectancy less than 48 hours；
* Possible surgey in the operating room in 24 hours；
* Myasthenia gravis;
* Serious hepatic dysfunction (CTP 10-15);
* Chronic kidney disease with glomerular filtration rate (GFR) \< 29 ml/min/1.73m2;
* Systolic blood pressure less than 90 mm Hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors;
* Acute severe neurological disorder and any other condition interfering with RASS assessment;
* Pregnancy or lactation;
* Unstable angina or acute myocardial infarction;
* Left ventricular ejection fraction less than 30%;
* Heart rate less than 50 beats/min;
* Grade 2 , second degree or third degree atrioventricular block in the absence of a pacemaker;
* Abuse of controlled substances or alcohol;
* Other conditions deemed unsuitable to be included;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05555667
Study Brief:
Protocol Section:
NCT05555667