Melatonin Versus Hydroxizin for Pre Operative Anxiety in Elderly Patients With Hip Fracture
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- preoperative anxiety
研究概览
简要总结
prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively
详细描述
prospective randomized trial including adukt patients scheduled for hip fracture surgery, Randomization into 2 groups: Group A: Hydroxizin peroperatively Group B: Melatonin pre operatively
Non inclusion criteria: patients with severe cognitive impairement Primary outcome pre operative anxiety assessed with Amsterdam preoperative anxiety and information scale
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult patients scheduled for hip fracture surgery
排除标准
- •Patients with contraindications for hydroxizine or Melatonin Patients with severe cognitive impairement
研究组 & 干预措施
Group A
patients of this group will receive 5 mg of Melatonin 12 hours and 5 mg 2 hours prior to surgery
干预措施: Melatonin 5 MG Sublingual Tablet (Drug)
Group B
patients of this group will receive 1 mg/kg of Hydroxizin 12 hours and 1 mg/ kg 2 hours prior to surgery
干预措施: Hydroxyzine (Drug)
结局指标
主要结局
preoperative anxiety
时间窗: 1 hour before surgery
preoperative anxiety scale
次要结局
未报告次要终点
研究者
Mhamed Sami Mebazaa
Professor head of anesthesia and intensive care department
Mongi Slim Hospital