Actualities in Procedural Sedation: Remimazolam
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Heart rate (beats per minute)
研究概览
简要总结
Remimazolam is a new, ultra-short-acting benzodiazepine approved in Romania for procedural sedation. It shows significant clinical benefits compared to other sedatives like Propofol or Midazolam, especially in elderly or high-risk patients. Advantages include better hemodynamic stability, reduced respiratory depression, lower incidence of postoperative delirium, and rapid recovery without residual sedation. It is metabolized by liver esterases and is less affected by organ dysfunction. Clinical studies suggest that remimazolam may be a safer and more effective alternative in procedural and general anesthesia. The findings support the development of institutional protocols for its use, particularly in high-risk populations and endoscopic procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Adults aged 65 years or older
- •ASA Physical Status classification III or IV
- •Patients scheduled to undergo endoscopic procedures requiring procedural sedation
- •Ability to provide written informed consent
排除标准
- •Age below 65 years
- •Pediatric population
- •Refusal or inability to provide informed consent
- •Severe allergy to study drugs
- •Pregnancy or breastfeeding
研究组 & 干预措施
Propofol
Lot 2 - Participants in this arm will receive Propofol for procedural sedation. Propofol will be administered intravenously according to standard clinical practice, with dosing adjusted to achieve adequate procedural sedation.
干预措施: Administering propofol (Drug)
Remimazolam
Lot 1 - Participants in this arm will receive remimazolam for procedural sedation. Remimazolam will be administered intravenously according to the institutional sedation protocol, with dosing adjusted to achieve adequate procedural sedation.
干预措施: Administering remimazolam (Drug)
结局指标
主要结局
Heart rate (beats per minute)
时间窗: Periprocedural
The lowest heart rate will be recorded
Mean arterial pressure (mmHg)
时间窗: Periprocedural
The lowest mean arterial pressure will be recorded
Incidence of hypotension requiring vasoactive support (Yes/No)
时间窗: Periprocedural
The presence of hypotension requiring vasoactive drug administration will be recorded.
次要结局
- Patient satisfaction(Postprocedural)
- Endoscopist satisfaction (5-point Likert scale)(Periprocedural)
- Quality of recovery (ordinal scale)(Periprocedural)
- Incidence of postoperative nausea and vomiting (Yes/No)(Periprocedural)
- Total dose of sedative administered (mg)(Periprocedural)
- Need for airway intervention due to apnea (Yes/No)(Periprocedural)
- Incidence of apnea (Yes/No)(Periprocedural)
- Peripheral oxygen saturation (SpO₂,%)(Periprocedural)
- Respiratory rate (breaths per minute)(Periprocedural)
- Duration of apnea (seconds)(Periprocedural)
- Need for change in sedation regimen (Yes/No)(Periprocedural)
- Incidence of postprocedural delirium (Yes/No)(Periprocedural)
- Incidence of adverse events (Yes/No)(Periprocedural)