Severe illness
Conditions
Interventions
Study group:Receive sedative therapy with the study drug.
control group:The control group received midazolam for sedation treatment.
Sponsors
Henan Provincial People's Hospita,medical
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients admitted to the Department of Critical Care Medicine requiring mechanical ventilation; 2.Expected to require sedation for =24 h after randomization, with a targeted sedation goal of RASS score -2 to +1; 3.Age =18 years, with no gender restriction; 4.Body mass index (BMI) of 18 kg/m² to 30 kg/m²; 5.The patient or legal representative has a full understanding of the purpose and significance of this trial, voluntarily participates in this clinical trial, and provides written informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients with contraindications or hypersensitivity to the study drugs; 2.Patients who have received sedation for more than 3 days in the ICU or in general wards before transfer to the ICU prior to providing informed consent; 3.Acute severe neurological diseases and any other conditions that interfere with RASS assessment; 4.Cardiovascular diseases: bradycardia requiring pharmacotherapy and/or heart rate = 50 bpm; second- to third-degree atrioventricular block (excluding patients with pacemaker); acute or chronic myocarditis; 5.Acute hepatitis or severe hepatic dysfunction (Child-Pugh Class C, see Appendix 7 for the scale); 6.Patients with chronic kidney disease with glomerular filtration rate (GFR) = 30 mL/(min·1.73 m²) (see Appendix 8 for calculation formula); 7.Patients with high paraplegia and general paralysis; 8.Patients with uncontrolled hemodynamics judged by the investigator (e.g., patients with systolic blood pressure < 90 mm Hg despite adequate intravenous fluid resuscitation and continuous infusion of two vasopressors, patients with shock, etc.); 9.Previous history of abuse of psychoactive drugs or anesthetic agents; history of alcohol abuse within 3 months before screening, long-term use of psychotropic drugs, etc; 10.Pregnancy and lactation period; 11.Participation in another clinical trial of investigational drugs within 1 month before screening; 12.Other conditions in which the investigator deems the patient unsuitable for enrollment in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sedation success rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in triglyceride levels;Study Drug Administration;Incidence of delirium;7-day ventilator-free days;Mechanical ventilation time;Vital signs;English Sedation success rate;Rate of successful sedation without early hypotension;Adverse events;Time to extubation;Patient survival;Recovery time;Length of ICU stay;Use of vasoactive agents; | — |
Countries
China
Contacts
Public ContactHuanzhang Shao
Henan Provincial People's Hospita,medical
Outcome results
None listed