Efficacy of Prophylactic Melatonin to Decrease the Incidence of Postoperative Delirium in Geriatric Patients Undergoing Surgeries Under General Anesthesia. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- postoperative delirium
研究概览
简要总结
POD has been reported to be associated with a large number of risk factors: age as POD occurs in 10% to 61% of those aged 65 or older, dementia, impaired left ventricular function, electrolyte disorder, alcoholism, smoking, high perioperative transfusion requirements, intraoperative pressure fluctuation, and use of benzodiazepine POD occurs mostly in some types of surgery, such as orthopedic surgeries, major gastrointestinal surgery, and major cardiovascular surgeries, surgery under general anesthesia, prolonged surgery, emergency surgery
Previous studies done before to prove the efficacy of melatonin to decrease the incidence of postoperative delirium in patients with multiple risk factors for POD as traumatic geriatric patients were concerned only with the type of surgery as hip replacement or with spinal anesthesia but no study was done before to assess the prophylactic effect of melatonin to decrease the incidence of postoperative delirium in geriatric patients under general anesthesia ,which represents an independent risk factor for POD. So,this double blinded RCT will try to fill this gap in literature.
详细描述
POD has been reported to be associated with a large number of risk factors: age as POD occurs in 10% to 61% of those aged 65 or older, dementia, impaired left ventricular function, electrolyte disorder, alcoholism, smoking, high perioperative transfusion requirements, intraoperative pressure fluctuation, and use of benzodiazepine POD occurs mostly in some types of surgery, such as orthopedic surgeries, major gastrointestinal surgery, and major cardiovascular surgeries, surgery under general anesthesia, prolonged surgery, emergency surgery
Previous studies done before to prove the efficacy of melatonin to decrease the incidence of postoperative delirium in patients with multiple risk factors for POD as traumatic geriatric patients were concerned only with the type of surgery as hip replacement or with spinal anesthesia but no study was done before to assess the prophylactic effect of melatonin to decrease the incidence of postoperative delirium in geriatric patients under general anesthesia ,which represents an independent risk factor for POD. So,this double blinded RCT will try to fill this gap in literature.
Aim of the study:
To prove the efficacy of melatonin to decrease the incidence of postoperative delirium after surgeries under general anesthesia in geriatric patients.
Methodology After approval of the Research Ethics Committee and written informed consent from all patients, A randomized, prospective, controlled, double blind study of the prophylactic effect of melatonin on postoperative delirium in geriatric patients undergoing surgeries under general anesthesia will be conducted on 100 patients allocated into 2 equal groups. The study will be conducted at Cairo University Hospitals, in all surgical units.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I-II
排除标准
- •ASA physical status ≥ III.
- •Allergy to the study drugs or one of their ingredients
- •Patients with Abbreviated Mental Test (AMT) score of< 6 ,
- •illiterate people,
- •preoperative sedation score >4,
- •History of alcohol abuse,
- •Sensory impairment (blindness, deafness),
- •Severe anemia (hematocrit<27%),
- •Intracranial events (stroke, bleeding, infection),
- •Fluid or electrolyte disturbances including dehydration, hyponatremia, hypernatremia,
- •Acute cardiac events: myocardial infarction, congestive heart failure exacerbation, arrhythmia,
- •Acute pulmonary events: asthma or chronic obstructive pulmonary disease exacerbation, pulmonary embolism, hypoxemia, hypercarbia -,Medications Anticonvulsants, Antidepressants, Antihistamines, Antiparkinsonian agents, Antipsychotics. And history of chronic sedative hypnotic use >3 times/week during a month prior to surgery
研究组 & 干预措施
M
will receive 5 mg melatonin orally at 9 p.m. the night before surgery and another 5 mg melatonin with 15 ml of plain water 30 min before operation and 5 mg melatonin at 9 p.m. in the day of operation and for the first three postoperative days
干预措施: melatonin effect on the Abbreviated Mental Test (Drug)
C
received a placebo in the form of one tablet of 500 mg paracetamol that packaged the same way as melatonin at the same times
干预措施: melatonin effect on the Abbreviated Mental Test (Drug)
结局指标
主要结局
postoperative delirium
时间窗: 3 postoperative days
Detection of the difference in incidence of POD between melatonin group and control group using the Abbreviated Mental Test (AMT)
次要结局
未报告次要终点
研究者
Sherif Abdullah Mohamed
Principal Investigator
Cairo University