Cerebral Vascular Effects of Dexmedetomidine Versus Propofol Sedation in Intubated Mechanically Ventilated ICU Patients With and Without Traumatic Brain Injury.
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Middle cerebral artery flow velocity
研究概览
简要总结
Serial transcranial Doppler (TCD) exams in healthy volunteers and in animal models showed a strong linear relationship between middle cerebral artery (MCA) flow velocity (FV) and dexmedetomidine infusion. The concomitant elevation of pulsatility index (PI) indicates vasoconstriction of the cerebral vasculature as the most profound underlying mechanism.
详细描述
Available clinical evidence on the use of dexmedetomidine sedation in neurosurgical and neurocritical care is limited and no definite conclusion can be drawn. There is a need for The use of dexmedetomidine might be a useful adjunct in clinical situations when the increase in CBF could be detrimental such as vasogenic cerebral edema (i.e., TBI, large brain tumors). However, dexmedetomidine sedation is questionable in patients with subarachnoid hemorrhage and acute stroke, since the associate drop in arterial pressure could worsen the coexisting increase in circulating catecholamines and massive sympathetic outflow. Further high-quality RCTs to evaluate the use of dexmedetomidine as a sedative agent both in general ICU patients and in patients with TBI.
Transcranial Doppler (TCD) is a simple noninvasive bedside tool to assess the cerebral blood flow pattern. The new development of transcranial color Doppler with angle correction option helps to improve the sensitivity of test results. TCD can assess the evolution of CBF alterations and possibly cerebral autoregulation performance and ICP estimation in patients presenting with cerebral pathology.
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)
盲法说明
double-blind
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult trauma patients (18-50 years old, ASA I-II).
- •With and without mild TBI.
- •Mild traumatic brain injury will include; brain edema, brain contusion, fracture base, fissure fracture and depressed fracture.
- •The severity of traumatic brain injury will be defined as mild based on basal Glasgow Coma Scale and basal Computerized tomography scanning.
- •Requirements of endotracheal intubation, mechanical ventilation and light to moderate sedation because of associated abdominal or chest traumatic injuries.
- •The sedation needed should of an estimated duration not less than 24h.
- •Baseline hemodynamic parameters within the normal range.
- •Baseline middle cerebral artery flow velocity within the normal range.
排除标准
- •Severe traumatic brain injury, subarachnoid hemorrhage and Intra-cerebral hemorrhage.
- •Spinal cord injury.
- •Hemodynamically unstable patients and patients on inotropes.
- •Patients who have a cardiac pacemaker or automatic implantable cardioverter defibrillator.
- •Patients with hepatic or renal impairment.
- •Pregnant females.
- •Patients who are incarcerated.
研究组 & 干预措施
DEX I
Trauma Patients without TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
干预措施: 0.2-0.7 mcg/kg/h dexmedetomedine infusion. (Drug)
DEX II
Trauma Patients with TBI received 0.2-0.7 mcg/kg/h dexmedetomedine infusion.
干预措施: 0.2-0.7 mcg/kg/h dexmedetomedine infusion. (Drug)
Propofol I
Trauma Patients without TBI received 10-70 mcg/kg/h propofol infusion.
干预措施: 10-70 mcg/kg/h propofol infusion. (Drug)
Propofol II
Trauma Patients with TBI received 10-70 mcg/kg/h propofol infusion.
干预措施: 10-70 mcg/kg/h propofol infusion. (Drug)
结局指标
主要结局
Middle cerebral artery flow velocity
时间窗: 24 hours
1. Right and left middle cerebral artery (MCA) will be measured via trans-temporal window and the depth of insinuation will be between 30-60 mm with the subject's head in neutral position. Mean values of simultaneously measured invasive blood pressure recordings and the outer envelope of time averaged MCA flow velocity (FV) recordings during ten consecutive cardiac cycles
次要结局
未报告次要终点
研究者
Hala Saad Abdel-Ghaffar
Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
Assiut University