Pain and physical discomfort
Conditions
Interventions
Ciprofol test group:Continuously infuse ciprofol injection intravenously at an initial rate of 0.25 mg/kg/h, with an adjustment range of 0 to 2.4 mg/kg/h
Control Group of Propofol Medium/Long Chain Fat Emulsion Injection:Continuously infuse Propofol Medium/Long Chain Fat Emulsion Injection intravenously at an initial infusion rate of 1mg/kg/h, with an
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged?= 18 years and ?=80 years, regardless of gender; 2.Those in need of deep sedation, expected to require deep sedation for >=24 hours; 3.The subject or their guardian has a full understanding of the purpose and significance of this trial, voluntarily participates in this clinical trial, and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Body Mass Index (BMI) 32kg/m²; 2.Known or suspected allergy to various components of the study drug, opioids, etc., or unsuitability for the use of fat emulsion (such as pancreatitis related to hyperlipidemia); 3.Expected survival time < 48h; 4.General anesthesia surgery is scheduled to be performed within 24 hours; 5.Undergoing extracorporeal membrane oxygenation (ECMO) treatment; 6.Myasthenia gravis; 7.Severe hepatic insufficiency (Child-Turcotte-Pugh (CTP) score of 10-15 points); 8.Severe chronic kidney disease (glomerular filtration rate (GFR) <= 29 ml/min/1.73m²); 9.Sustained systolic blood pressure (SBP) above 90 mmHg can only be maintained with 1µg/kg/min norepinephrine bitartrate (or other vasoactive drugs converted to equivalent doses) despite adequate fluid resuscitation; 10.Those who cannot accurately undergo RASS assessment for various reasons, such as those with a history of mental system diseases (history of schizophrenia, mania, mental confusion, cognitive dysfunction), status epilepticus, continuous intravenous infusion of muscle relaxants, severe craniocerebral injury or coma, etc.; 11.Pregnancy or lactation; 12.Unstable angina pectoris or acute myocardial infarction; 13.Left ventricular ejection fraction of 30% or less; 14.Heart rate < 50 bpm (those whose heart rate can be maintained above 50 with drug intervention may not be excluded); 15.2°II type or 3° atrioventricular block (those with a pacemaker implanted may not be excluded); 16.Those with a history of drug abuse, drug addiction, alcoholism, or long-term use of psychiatric drugs within 2 years before the start of the screening period. Alcoholism is defined as regular drinking exceeding 14 times a week (1 time = 150ml of wine, 360ml of beer, or 45ml of spirits); 17.Judged by the researchers as unsuitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The RASS compliance rate at which subjects maintain the target sedation level (between RASS -3 and -5) without using the sedative drugs of the study medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time-weighted average dosage of vasoactive drugs (calculated as norepinephrine bitartrate in µg/kg/min);Fluid balance;7 days without invasive mechanical ventilation time;Length of stay in this ICU within 7 days;28-day all-cause mortality rate; | — |
Countries
China
Contacts
Public ContactShang You
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed