Effect of Dexmedetomidine on Brain Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glasgow Coma Scale (number)
研究概览
简要总结
The aim of the study is to check whether dexmedetomidine has neuroprotective properties in brain injury patients. The enrolled 60 patients will be divided into two groups; Group 1(n=30): are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.
详细描述
- Approval will be obtained from the Research Ethics Committee of Faculty of Pharmacy, Damanhour University.
- All participants must agree to take part in this clinical study and provide informed consent.
- The required sample size will be calculated.
- 60 Patients with brain injury will be enrolled from the intensive care department, Damanhour medical national institute.
- Serum samples will be collected for measuring the biomarkers.
- All enrolled 60 patients will be mentioned as two groups; Group 1(n=30): are the patients who will receive dexmedetomidine. Group 2 (n=30): are the patients who represent the control group.
- All patients will be followed up during their stay in the intensive care department.
- During their stay in the intensive care department, step 5 will be repeated.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Measuring outcomes: the primary outcome is measuring the neuroprotection provided by dexmedetomidine reflected by change in patients' symptoms, while secondary outcome is the change in the level of biomarkers from baseline to post-treatment.
- Results, discussion, conclusion, and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 Patients with brain injury with age ranging from 18 to 70 years, there are no limits to gender.
排除标准
- •Patients with significant liver impairment
- •Patients with known heart failure
- •Patients with hypotension
- •Patients with bradycardia
研究组 & 干预措施
Placebo Group
30 brain injury patients will treated with Placebo Normal Saline 2ml (Intravenous infusion).
干预措施: Placebo (Other)
Dexmedetomidine Group
30 brain injury patients will treated with Dexmedetomidine 200 mcg/ 2 mL (Intravenous infusion).
干预措施: Dexmedetomidine Injectable Solution (Drug)
结局指标
主要结局
Glasgow Coma Scale (number)
时间窗: 1 week
GCS The highest possible 15, and the lowest is 3. A score of 15 means fully awake, responsive and have no problems with thinking ability or memory. Generally, having a score of 8 or fewer means a coma. The lower the score, the deeper the coma is.
length of intensive care department stay (days)
时间窗: 1 month
length of intensive care department stay.
次要结局
- Neuron Specific Enolase (ng/ml)(1 Week)
- tau protein (ng/L)(1 Week)
研究者
Rehab Werida
Associate Professor
Damanhour University