Mechanical ventilated patients requiring sedation in the ICU
Conditions
Interventions
Experimental group:Sedation with remazolam besylate
Control group:Sedation with dexmedetomidine
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. Accept invasive mechanical ventilation; 3. It is expected that the extubation condition cannot be reached within 48 hours; 4. Need to use sedative drugs to ensure comfort, safety and to promote the implementation of life support measures; 5. Subjects or their authorized principals gave informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation; 2. Patients who need deep sedation to assist special treatments such as prone position and muscle relaxants; 3. Has been intubated in the ICU (excluding intubation time in the operating room or transport) for more than 12 hours; 4. MAP pressure <50 mmHg after adequate fluid resuscitation and vasopressor therapy; 5. Heart rate < 55 beats/min, except for patients who are receiving beta-blockers or advanced atrioventricular block therapy without a functional pacemaker; 6. Confirmed or suspected spinal cord injury or other pathological conditions that may lead to permanent or long-term debilitation; 7. Cardiac insufficiency, left ventricular EF<=30%; 8. Severe craniocerebral injury, Glasgow score (GCS) < 8; 9. Liver function damage (Child-Pugh C level); 10. Renal insufficiency (acute: AKI grade 3, chronic: CKD stage 3 and above); 11. The patient is in critical condition and has a poor prognosis, and the patient or authorized client gave up treatment before the start of the trial; 12. Myasthenia gravis patients; 13. Patients with bronchial asthma; 14. Allergic to the research drug or ingredient; 15. The patient participates in other clinical trial studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of sedation within 48 hours of randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs;the time of mechanical ventilation; | — |
Countries
China
Contacts
Public ContactShao Huanzhang
Henan Provincial People's Hospital
Outcome results
None listed