Significantly Reduced Median Effective Dose (ED50) of Remimazolam for Anesthesia Induction in Frail Elderly Patients: A Prospective Dose-Finding Clinical Trial With Respiratory Volume Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Sedation Success (Loss of Consciousness)
研究概览
简要总结
This study aimed to determine the median effective dose (ED50) of remimazolam for loss of consciousness (LOC) in elderly and frail elderly patients using the Dixon up-and-down method, while utilizing a novel Respiratory Volume Monitor (RVM) to detect subclinical respiratory depression.
详细描述
The physiological decline associated with frailty in elderly patients presents significant challenges for anesthesia induction. Remimazolam tosilate, an ultra-short-acting benzodiazepine, offers a promising safety profile, yet its optimal dosing in frail populations remains undefined. This prospective, up-and-down sequential allocation trial was conducted at the Second Hospital of Hebei Medical University. 58 patients aged ≥65 years undergoing elective surgery were stratified into two groups: an Elderly Group (Clinical Frailty Scale [CFS] < 5) and a Frail Elderly Group (CFS ≥ 5). The initial remimazolam induction dose was set at 0.15 mg/kg for the elderly group and 0.13 mg/kg for the frail group, with dose adjustments based on the previous patient's response. A non-invasive RVM was employed to continuously monitor Tidal Volume (VT) and detect early hypoventilation.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥65 years;
- •Scheduled for elective surgery under general anesthesia with endotracheal intubation;
- •American Society of Anesthesiologists (ASA) physical status II or III;
- •Body Mass Index (BMI) between 18 and 30 kg/m².
排除标准
- •Known allergy to benzodiazepines;
- •History of severe respiratory or cardiovascular disease (e.g., acute heart failure, severe COPD);
- •Long-term use of sedatives, analgesics, or alcohol abuse;
- •Known neuromuscular disorders (e.g., myasthenia gravis);
- •Inability to communicate for sedation assessment.
研究组 & 干预措施
Elderly Group (Non-Frail)
Patients with a Clinical Frailty Scale (CFS) score < 5.
干预措施: Remimazolam Tosilate (Drug)
Frail Elderly Group
Patients with a Clinical Frailty Scale (CFS) score ≥ 5.
干预措施: Remimazolam Tosilate (Drug)
结局指标
主要结局
Sedation Success (Loss of Consciousness)
时间窗: up to 2 minutes
Defined as the achievement of Loss of Consciousness (LOC) confirmed by loss of eyelash reflex, no response to verbal commands, Ramsay Sedation Score ≥ 5, and MOAA/S score \< 1.
次要结局
- Median Effective Dose (ED50) of Remimazolam(Perioperative/Periprocedural)
- Changes in Tidal Volume (VT)(Baseline, 30 seconds, 60 seconds, 90 seconds, and up to 120 seconds post-administration)
- Mean Arterial Pressure (MAP)(Baseline and up to 2 minutes post-administration)
- Heart Rate (HR)(Baseline and up to 2 minutes post-administration)
研究者
Yanjie Yang
Principal investigator
The First Hospital of Hebei Medical University