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

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

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.

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)。