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:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-24 @ 11:09 PM
NCT ID:
NCT02080169
Eligibility Criteria:
Inclusion Criteria:
1. ICU patients needing sedation
2. 18 years or older
3. mechanically ventilated for less than 96 hours prior to start of study drug.
Exclusion Criteria:
1. Trauma and burn patients as admitting diagnosis.
2. Dialysis of all types.
3. Pregnant or lactation.
4. Neuromuscular blockade other than for intubation.
5. Epidural or spinal analgesia.
6. General anesthesia prior to or planned after the start of study drug infusion
7. Serious central nervous system pathology(acute stroke, uncontrolled seizures,severe dementia).
8. Acute hepatitis or severe liver disease (Child-Pugh class C).
9. Unstable angina or acute myocardial infarction.
10. Left ventricular ejection fraction less than 30%,heart rate less than 50/min. 11.Second or third degree heart block.
12.Allergy to the study drug. 13.Systolic blood pressure less than 90 mm Hg despite continuous infusions of 2 vasopressors before the start of study drug infusion.
14\. Patients with renal insufficiency were randomized and treated; however, patients were discontinued if they required dialysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02080169
Study Brief:
Protocol Section:
NCT02080169