The Efficacy of Oral Melatonin in Preventing Postoperative Delirium for Patients Undergoing Orthopedic Surgery Under General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
研究概览
简要总结
Postoperative delirium is a complication that should not be underestimated. As it elaborates many complications that could be avoided when an accurate assessment of the risk factors and interventional measures are taken appropriately when needed.
详细描述
Delirium is a variation in concentration capabilities that occurs acutely in association with a disturbed level of consciousness. Delirium is more common in orthopaedic surgery patients than in general surgery patients. As delirium ratios range from 44% to 55% in hip surgery patients, otherwise only 10%-14% of general surgery patients. Several studies were carried out and found that melatonin levels correlate with the development of delirium postoperatively. This study was conducted to determine the efficacy of administering melatonin preoperatively in patients undergoing orthopedic surgery to prevent postoperative delirium.
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)
盲法说明
It has been done on all the study's contributors and workers.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1- Patients in good general health.
- •Baseline MDAS <
- •No seizure disorder.
排除标准
- •Patients with a neurological disorder (e.g., dementia, stroke, epilepsy).
- •Patients with a history of acute or chronic confusion.
- •Patients taking centrally acting drugs (e.g., antidepressants, antiparkinsonian drugs, sedatives, monoamine oxidase inhibitors), or alcohol abusers.
- •Patients who have medical disorders predisposing to delirium (e.g. cachexia, thyroid dysfunction, renal failure).
研究组 & 干预措施
Control Group
Patients in this group received nothing for sedation.
干预措施: No intervention (Other)
Midazolam group
7.5 mg of Midazolam were given orally the night before operation. Another dose 90 min. preoperatively.
干预措施: Midazolam (Drug)
Melatonin group
5 mg of Melatonin were given orally the night before operation. Another dose 90 min. preoperatively
干预措施: Melatonin (Drug)
结局指标
主要结局
The efficacy of oral Melatonin in preventing Postoperative Delirium after general anesthesia
时间窗: 1 week
This interventional trial is done to determine the efficacy of preoperative melatonin administration in reducing postoperative delirium rates.
次要结局
未报告次要终点
研究者
Hashim Talib Hashim
Principal Investigator
University of Baghdad