Assessment Role of Mgso4 as Neuroprotective in Post Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glasgow outcome scale after 2 months
研究概览
简要总结
The aim of this study is to assess the potential role of magnesium sulphate (MgSo4) as a neuroprotective agent using the Glasgow outcome scale following moderate and severe traumatic brain injury.
详细描述
The study is Prospective , Comparative , double-blind , placebo-controlled study with randomization
Patients with post traumatic brain injury either moderate (glasgow coma scale GCS = 9-12) or severe (GCS = 3-8) admitted in one of the neurosurgical ICU of the following centers; kasr El Aini Hospitals, Beni- Suef University Hospital or Beni- Suef General Hospital.
Study design and statistical inferences Patients with traumatic brain injury included in the study will be randomly allocated into one of two equal groups (30 patients each): -
Group (A): will receive MgSo4. Group (B): will receive normal saline as a placebo.
Each patient will receive all other standard management as indicated on individual basis (e.g. Antiepileptics, brain dehydrating measures, antibiotics, ventilatory support, or surgical intervention when deemed necessary).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The researcher did not know the type of medication given to the patients, placebo or treatment actually Only investigator knew the key
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with moderate (GCS = 9-12), or severe (GCS = 3-8) traumatic brain injury.
- •Age above 12 years.
- •Consenting for treatment within 24 hours of trauma.
排除标准
- •Non consenting patients.
- •Persistent hypotension (BP below 90 / 60) in 1st 24 hours despite measures of resuscitation.
- •Significant multisystem association (e.g. cord injury with spinal shock).
- •Known case of renal failure
研究组 & 干预措施
intervention arm ( Group A )
including 30 patients Group A was given magnesium Sulphate
Administration regimen of Mgso4 was as following:
Initial dose: within 24 hrs of trauma 50 mg / kg / IV infusion over 1 hour. Maintenance dose: (25 mg / kg) per dose twice daily for 48 hrs.
干预措施: Magnesium Sulfate (Drug)
Placebo arm (Group B )
including 30 patients Placebo control study Group B was given saline as a placebo. with the same regimen and route of administration of magnesium sulphate
干预措施: Placebo (Drug)
结局指标
主要结局
Glasgow outcome scale after 2 months
时间窗: 60 days from drug administration
assessment of conscious level of the patients after 60 days of drug administration The Glasgow outcome scale (GOS) has been used to categorize the outcome after 2 months as follows: 1. Death. 2. Persistent vegetative state: Minimal responsiveness. 3. Severe disability: Conscious but disabled; dependent on others for daily support. 4. Moderate disability: Disabled but independent; can work in sheltered setting. 5. Good recovery: Resumption of normal life despite minor deficits. Better score means that the patient conscious level is improved
次要结局
未报告次要终点
研究者
Osama Mohamed Abdelwahab
Professor Osama Mohamed Abdelwahab
Cairo University