Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.
详细描述
Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions, the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients. Also, The present study aimed to assess the value of oral melatonin 5mg and 10mg given perioperatively on sleep quality in patients submitted to total hip arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective unilateral total hip arthroplasty.
排除标准
- •Revision arthroplasty
- •documented sleep disorders requiring treatment,
- •use of other sleep medications preoperatively
- •known melatonin allergy or contraindication.
研究组 & 干预措施
5mg group
Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.
干预措施: Melatonin 5 MG (Drug)
10mg group
Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.
干预措施: Melatonin 10 MG (Drug)
结局指标
主要结局
Sleep Quality
时间窗: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) for sleep quality
次要结局
未报告次要终点
研究者
Nourhan Elsayed Mohamed Amer
Principal investigator
Benha University