PK/PD Properties and Safety of Remazolam Besylate for Injection in ICU Patients With Impaired Renal Function

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)。