NCT06153498已完成不适用
A Randomized Study of the 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 Technology1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月4日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)。
研究组 & 干预措施
Normal renal function group
Experimental
干预措施: Remimazolam besylate (Drug)
Renal injury group
Experimental
干预措施: Remimazolam besylate (Drug)
结局指标
主要结局
Cmax
时间窗: Within 24 hours while receiving the study drug
peak plasma concentration
The area under the plasma drug concentration-time curve
时间窗: Within 24 hours while receiving the study drug
The area under the plasma drug concentration-time curve (AUC)
t1/2
时间窗: Within 24 hours while receiving the study drug
half-life
次要结局
- The percentage of time in the target sedation range without rescue sedation(Within 24 hours while receiving the study drug)
- The number and severity of treatment emergent adverse events (TEAEs)(Within 24 hours while receiving the study drug)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Critically Ill Patients With Deep SedationCritically IllDeep SedationNCT05539521Wuhan Union Hospital, China60
Enrolling By Invitation
不适用
RCT Comparing Remimazolam With Propofol Under EEG DSA Guidance During Cardiac Electrophysiology Studies and AblationHemodynamicRemimazolamPropofolCardiac ElectrophysiologyNCT06700681Taipei Veterans General Hospital, Taiwan200
已完成
2 期
Efficacy and Safety of Remimazolam Besylate Versus Propofol for Sedation in Mechanically Ventilated ICU PatientsCritical IllnessNCT04790734Wuhan Union Hospital, China60
已完成
1 期
Pharmacokinetics Study in Patients With Impaired Renal Function and Subjects With Normal Renal FunctionPatients With Impaired Renal FunctionNCT02603497Astellas Pharma Inc31
Enrolling By Invitation
4 期
Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With SepsisSepsisNCT06731088First Affiliated Hospital of Ningbo University100