Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Melatonin level
研究概览
简要总结
Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory.
In this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery
详细描述
Patients with Glasgow coma scale (GKS) >14, American Society of Anesthesiologist (ASA) I-III, intensive care patients underwent transcranial surgery will be included
Patients will be randomly allocated by a computer generated random numbers list into two groups.
Patients with sleep disruptions (Group I) (exposed to ambient light and noise) and Patients without sleep disruptions (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
Melatonin levels will be measured by urine 6-sulfatoxymelatonin (a-MT6) levels, which is a product of melatonin degradation at 07:00 am preoperative and postoperative day 1 and day 3.
Plasma Interleukin-1 (IL-1), Interleukin- 6 (IL-6),C-reactive protein (CRP) levels will be measured at 07:00 am preoperative and postoperative day 1and day 3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glasgow Coma Scale(GCS) >14
排除标准
- •Glasgow Coma Scale(GCS) <14
- •Patients who do not understand the questions, not awake
- •Patient who treated with hormones
- •Patient with infection or inflammatory disease
研究组 & 干预措施
Group Isolated
Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)
干预措施: Group Isolated (Other)
Group Disrupted
Group Disrupted (Group I) (exposed to ambient light and noise)
结局指标
主要结局
Melatonin level
时间窗: 07:00 am postoprative day 3
Melatonin will be measured urine 6-sulphatoxymelatonin
次要结局
- IL-1,IL-6,CRP(: at 7 o'clock in the morning preoperative day, 7 in the morning on the first postoperative day and 7 in the morning on the third postoperative day hour)
研究者
Emine Arik
Specialist in Anesthesia
Diskapi Yildirim Beyazit Education and Research Hospital