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

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Mechanically Ventilated Patients

Interventions

Remimazolam besylateDRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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)。

Locations (1)

Wuhan Union Hospital

Wuhan, Hubei, China