The Effect of Melatonin on Anxiety and Sleep Quality in the Peri-Operative Course of Adults Undergoing Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quality of sleep
研究概览
简要总结
The objective of this study is to evaluate the effect of melatonin on post operative sleeping quality, anxiety, and post-operative opioid requirements in adults post coronary artery bypass graft (CABG) surgery.
详细描述
Sleep disturbance is common among patients undergoing coronary artery bypass graft (CABG), especially during the first week of the postoperative period. Sleep disorders result in important impacts on morbidity, mortality, and quality of life.
Many factors are thought to be the cause of sleep disturbance in patients who have undergone CABG. These factors include environmental stimuli (e.g. noise and uncomfortable beds), individual characteristics (e.g. primary sleep disorder and comorbid health), nature of cardiac illnesses, and surgical complications (e.g. incisional pain, use of diuretics and resultant nocturia, dyspnea, and difficulty in finding the proper position to sleep).
Furthermore, decreased plasma melatonin concentrations have been documented during surgery and the postsurgical period in patients having undergone CABG.
Melatonin is a neurohormone originating from the amino acid, tryptophan, and is mainly secreted by the pineal gland into the blood stream and the cerebrospinal fluid. It possesses a circadian secretion pattern with a low blood concentration during the day and a high concentration at night.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 40-60 years.
- •Both sexes.
- •Patients undergoing standard on-pump CABG with the same technique by the same surgical team.
排除标准
- •Refusal of procedure or participation in the study by patients.
- •Patients with known history of allergy to one of study drugs
- •Patients taking psychiatric medications, CNS depressants, and hypnotic drugs.
- •Patients with neurological disorders stroke, intracranial hemorrhage and surgery.
- •Patients with a history of suffering from any sleep disorder.
- •Severe circulatory or respiratory disease.
- •Patients with obstructive sleep apnea.
- •Cognitive or psychiatric illness that leads to inability to cooperate, speak or provide informed consent
研究组 & 干预措施
Control group
Patients in the control group will receive placebo.
干预措施: Placebo (Other)
Melatonin group
Three days before the operation patients will receive 5 mg of melatonin (Melatonin, Nature Made, Canada, and USA) one hour before assigned sleep time until the time of discharge from hospital.
干预措施: Melatonin 5 MG (Drug)
结局指标
主要结局
Quality of sleep
时间窗: Five days postoperative
Sleep quality will be evaluated using the Groningen Sleep Quality Score (GSQS), The GSQS consists of 15 questions about the previous night's sleep, answered with Yes or No.
次要结局
- Anxiety(24 hours postoperative)
- The degree of pain(24 hours postoperative)
- Opioid requirements(24 hours postoperative)
研究者
Ahmed ashraf abdelaziz bayoumi
Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Ain Shams University, Egypt.
Ain Shams University