Randomised Double-blind Placebo-controlled Study of Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Incidence of post-operative delirium
研究概览
简要总结
In this study the investigators want to determine if treatment with haloperidol direct post-operatively after acute hip surgery in high risk patients protects against developing a post-operative delirium.
详细描述
A post-operative delirium is a serious and frequent (35-65%) complication with high morbidity and mortality in high risk patients. In this study we investigate whether we can prevent a delirium from occuring after surgery in patients with a hip fracture of 75 years of age and older. It's a randomised double-blind single centre placebo-controlled study of haloperidol versus placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Hip fracture
- •75 years and older
排除标准
- •Contra-indications for the use of haloperidol
- •Pre-operative delirium
- •Pre-operative use of haloperidol
研究组 & 干预措施
A
Patients receiving blinded medication (Haloperidol or Placebo)
干预措施: Haloperidol (Drug)
B
Patients receiving blinded medication (Haloperidol or Placebo)
干预措施: placebo (Drug)
结局指标
主要结局
Incidence of post-operative delirium
时间窗: 72 hours post surgery
次要结局
- Length of stay(days)
- Complications(during hospitalization)