The Impact of Melatonin on the Postoperative Delirium in Geriatric Patients After Colorectal Surgeries. A Randomised Placebo-controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of delirium occurrence
研究概览
简要总结
The present study will evaluate the role of melatonin prophylaxis in delirium prevention in elderly patients undergoing colorectal procedures.
详细描述
This study is a prospective randomised double-blind placebo-controlled trial. Patients who meet the criteria for inclusion/exclusion will be evaluated. Melatonin tablets will be administered as a premedication to patients in the melatonin group. Patients in the control group will be given placebo tablets as a premedication. Fentanyl 1ug/kg and propofol 1-2 mg/kg will be used to induce anaesthesia. Atracurium 0.5 mg/kg will be used for the facilitation of endotracheal intubation. Isoflurane will be used to maintain anaesthesia and the depth of anaesthesia will be adjusted by a Bispectral index monitor. Postoperatively, the patients will be monitored for the development of 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)
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
- •American Society of Anaesthesiologists (ASA) I to III physical status
- •Elective colorectal procedures
排除标准
- •Allergy to the research drugs,
- •Patients who have vision or hearing impairment
- •History of cerebral disorders
- •Uncorrected acid-base, fluid, and electrolyte abnormalities
- •History of central nervous system function affecting drugs.
- •Chronic sedative-hypnotic administration at least one month prior to surgery
- •Alcohol abuse
- •Patients with recorded preoperative nursing delirium screening score ≥ 2.
研究组 & 干预措施
Melatonin group
The patients will be given 5 mg melatonin the night before surgery, 12 hours before the scheduled time of surgery, followed by another 5 mg melatonin two hours before surgery.
干预措施: Melatonin (Drug)
Control group
The patients will be premedicated with placebo tablets, which will be administered at the same times as the melatonin group.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of delirium occurrence
时间窗: Perioperative.
Nursing delirium - screening score. It scores five items,Each item is rated from 0 to 2 where 0, absent; 1, mild; 2, severe. A score ≥ 2 is considered to have delirium.
次要结局
- Blood transfusion needs(Perioperative)
- Mean arterial blood pressure(Perioperative)
- Heart rate(Perioperative)
- Hypotension(Perioperative)
- Hypoxia(Perioperative)
- Intensity of pain(Perioperative)
- Degree of Sedation(Perioperative.)
研究者
Abd-Elazeem Abd-Elhameed Elbakry
Assistant professor
Menoufia University