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 @ 3:21 PM
Ignite Modification Date:
2025-12-24 @ 3:21 PM
NCT ID:
NCT06454292
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged ≥18 years and ≤80 years;
2. Admitted to the ICU and undergoing invasive mechanical ventilation with an expected duration of mechanical ventilation of more than 24 hours;
3. Subjects requiring sedation and analgesia;
4. Subjects or their guardians voluntarily participate in the study and sign an informed consent form;
Exclusion Criteria:
1. Pregnant or breastfeeding women;
2. Hypersensitivity to opioids (fentanyl, remifentanil, sufentanil, morphine, etc.);
3. Subjects with bronchial asthma attacks;
4. Subjects with acute intestinal obstruction;
5. Subjects who are unable to undergo RASS and CPOT assessments for various reasons, such as those with a history of psychiatric systemic disorders (schizophrenia, mania, psychosis, history of cognitive dysfunction), grand mal status epilepticus, and craniocerebral injury;
6. Severe hemodynamic instability (subjects who require administration of more than an equivalent dose of 0.5 μg/kg/min norepinephrine to maintain a MAP ≥ 65 mmHg and who, in the opinion of the investigator, are not suitable for enrollment);
7. Use of monooxygenase inhibitors (MAOIs) (see protocol appendix);
8. Chronic pain requiring long-term analgesic medication (duration of illness greater than 3 months);
9. Severe hepatic insufficiency (liver function in Child classification C);
10. Severe renal dysfunction (definition of renal dysfunction: chronic renal insufficiency \[glomerular filtration rate (GFR) ≦29ml/(min1.73m3\]; or long-term maintenance hemodialysis or peritoneal dialysis subjects);
11. Undergoing any clinical trial within 1 month prior to enrollment and receiving the test product;
12. ECG QT interval at screening: \>450 ms for men and \>470 ms for women;
13. Subjects with a desired sedation target RASS score within the range of -5 to -3 (including threshold) points;
14. Other conditions deemed unsuitable for enrollment by the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06454292
Study Brief:
Protocol Section:
NCT06454292