Mechanically Ventilated Patients
Conditions
Brief summary
Pharmacokinetic/pharmacodynamic profiles of remazolam besylate were compared in patients with impaired and normal renal function in the ICU, and safety was assessed by recording hemodynamic parameters and adverse events.
Interventions
DRUGRemimazolam besylate
After a loading dose of 0.05mg/kg, a maintaining dose of 0.2mg/kg/h is given; It is recommended to adjust the infusion rate of Remazolam besylate for injection at a amplitude of 0.05mg/kg/h, mainly based on the RASS score of the subjects (the adjustment range is 0-1.0 mg/kg/h, and the maximum infusion rate is not more than 1.0mg/kg/h) until the subjects reach the optimal sedation level (-3≤RASS≤0).
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age ≥18 and ≤80 years, regardless of gender; * Anticipated requirement for mechanical ventilation and sedation ≥24 hours; * arget sedation level within RASS score range of -3 to 0 (inclusive); Patients with renal impairment were defined as having a glomerular filtration rate (GFR) \<90 mL/min/1.73m². Patients with normal renal function were defined as having a glomerular filtration rate of 90 to 120 ml/min/1.73m2
Exclusion criteria
* BMI\<18 or \>30kg/m2; * Hypersensitivity to study drugs/opioids/reversal agents; * Life expectancy \<48 hours; * Scheduled surgery requiring general anesthesia within 24h; * Myasthenia gravis; * Moderate-severe hepatic impairment (Child-Pugh ≥B); * Severe CKD (eGFR \<30 mL/min/1.73m²) or renal replacement therapy within 3 days; * Recent benzodiazepine use (≤1 week) or chronic benzodiazepine dependence; * Hemodynamic instability (≥2 vasopressors to maintain SBP \>90 mmHg); * Inability to perform RASS assessment (e.g., major neuropsychiatric disorders, coma); * Pregnancy/lactation; * Acute coronary syndrome or severe cardiac dysfunction (LVEF ≤30%, advanced heart block, HR\<50 bpm without pacing); * Active ECMO/IABP support; Substance abuse history (≤2 years)。
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Within 24 hours while receiving the study drug | peak plasma concentration |
| The area under the plasma drug concentration-time curve | Within 24 hours while receiving the study drug | The area under the plasma drug concentration-time curve (AUC) |
| t1/2 | Within 24 hours while receiving the study drug | half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of time in the target sedation range without rescue sedation | Within 24 hours while receiving the study drug | The percentage of time in the target sedation range without rescue sedation |
| The number and severity of treatment emergent adverse events (TEAEs) | Within 24 hours while receiving the study drug | The number and severity of treatment emergent adverse events (TEAEs) |
Countries
China
Outcome results
None listed