The Effect of Melatonin Administration on Sedation Level as Adjuvant to Propofol in Mechanically Ventilated Traumatic Brain Injury Patient: RCT
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- level of sedation
研究概览
简要总结
This study assess the effect of administration of exogenous melatonin as adjuvant to propofol on the level of sedation and consequently the rate of propofol infusion.
详细描述
38 patients with traumatic brain injuries requiring mechanical ventilation and sedation were randomly allocated to two groups (melatonin group)19 patients and (control group)19 patients. In both groups a bolus of propofol 1mglkg was given by titration till the patient reached a sedation level value of (60-70) on the bispectral index (BIS), Then propofol infusion started at a rate of 1mglkglhr as a maintenance and rate adjusted according to our targeted sedation level, melatonin 10 mg tablet was crushed and mixed with 20 ml of water and administrated through a nasogastric tube followed by another 20 ml to flush out the residue for (melatonin group). While (control Group) received a placebo tablets by the same wayBIS value and propofol infusion rate was recorded over 12 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
patient will be under general sedation
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
- •Age group from 18 to 65
- •Both sexes
- •Patients on a mechanical ventilation and need sedation
- •Patients who are vitally stable
排除标准
- •Gastro intestinal tract impractabililty
- •Pregnant female
- •Vitally unstable patients who cannot tolerate propofol infusion
研究组 & 干预措施
propofol and melatonin
propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.
干预措施: Propofol (Drug)
propofol and melatonin
propofol iv infusion and melatonin 10 mg tablet through a nasogastric tube, once at admission.
干预措施: Melatonin 10 MG Oral Tablet (Drug)
propofol and placebo
propofol iv infusion and a placebo tablets through a nasogastric tube once at admission
干预措施: Propofol (Drug)
propofol and placebo
propofol iv infusion and a placebo tablets through a nasogastric tube once at admission
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
level of sedation
时间窗: 6 hours
observe the effect of the oral administration of 10 mg melatonin on decreasing the dose of propofol infusion in a mechanically ventilated patient with a traumatic brain injury using bispectral index
次要结局
- • Arterial blood pressure(6 hours)
- Heart rate(Measuring the heart rate as beats per minutes just before and after propofol infusion and every hour for the next 6 hours)