Propofol or Benzodiazepine Combined With Ketamine for Procedural Sedation in Emergency Setting
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Induction and recovery time for both combinations
研究概览
简要总结
This single blinded parallel randomized clinical trial will be conducted on 50 patients presented to Emergency Department of Alexandria Main University Hospital who are indicated for procedural sedation. All patients included in the study will be allocated randomly using computer software with concealment of randomization in to two groups:
- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg)
- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg) Additional ketamine (0.25 mg/kg) will be administered in case of inadequate sedation in both groups.
the two groups will be compared as regard incidence of complications World Society of Intravenous Anesthesia (SIVA) international sedation task force to standardize reporting adverse events
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥18 years) requiring procedural sedation and analgesia for painful procedures in ED . The following procedures are indications for PSA:
- •Cardioversion
- •Reduction of fracture or joint dislocation
- •Procedures as central venous catheter (CVC) and chest tube insertion or wound management
排除标准
- •Patients with anticipated difficult airway.
- •Post cardiac arrest patients.
- •Contraindication to study drugs.
- •Pregnant women.
- •Patients > 65 years.
研究组 & 干预措施
midazolam- ketamine combination
- Group A: 25 patients will receive ketamine (0.5 mg/kg) plus midazolam (0.05 mg/kg
干预措施: ketamine- midazolam versus ketamine- propofol (Drug)
propofol- ketamine combination
- Group B: 25 patients will receive ketamine (0.5 mg/kg) plus propofol (0.5 mg/kg)(
干预措施: ketamine- midazolam versus ketamine- propofol (Drug)
结局指标
主要结局
Induction and recovery time for both combinations
时间窗: 2 hours
the induction and recovery time of ketamine/midazolam versus ketamine/propofol combinations used for procedural sedation in an Emergency setting.
次要结局
- incidence and severity of adverse events(2 hours)