Stellate Ganglion Block Combined With Dexmedetomidine or Subanesthetic Ketamine Infusion for Treatment of Neurostorm After Traumatic Brain Injury in Critically Ill Patients: A Randomized Clinical Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 1
- 主要终点
- To compare the time of remission of neurostorm symptoms
研究概览
简要总结
Neurostorming is a sudden and exaggerated stress response as a result of damage to the brain. With appropriate treatment and time, there is hope for individuals to overcome storming, regain consciousness, and work towards successfully recovering from brain injury. Most treatments for neurostorming involve the use of medications only such as dexmedetomidine, opioids, gabapentin and propofol to address secondary complications like high blood pressure and fever. These medications focus on slowing the body's stress response or relaxing the body. Stellate ganglion block (SGB) is a promising therapy for paroxysmal sympathetic hyperactivity (PSH), overcoming the limitations of systemic medications and may serve to recalibrate aberrant autonomic states. Ketamine is a potent dissociative agent which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Its combination with stellate ganglion block is to oppose its sympathomimetic effect. Dexmedetomidine has analgesic and sedative effect which inhibits the sympathetic nerve activity through its action on the α2 receptor in the spinal cord. Hypothesis: Null hypothesis: There is no difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.Alternative hypothesis: There is a difference between the effects of stellate ganglion block combined with dexmedetomidine or subanesthetic ketamine infusion for treatment of neurostorm after traumatic brain injury in critically ill patients.which has sedative, analgesic and anesthetic properties beside its sympathomimetic effect. Aim of the work is achievement of effective treatment for the neurostorm after traumatic brain injury in critically ill patients with better outcomes and decrease intensive care unit (ICU) stay.
详细描述
PATIENTS AND METHODS
I. Technical Design:
- Site of study:
This study will be carried out in the emergency intensive Care unit (ICU) of Zagazig University Hospitals within 6 months. 2. Sample size:
The sample size was collected using G power version 3.1.9.7 according to the following expected moderate effect size between stellate ganglion plus dexmedetomidine group (SD group) and stellate ganglion block plus ketamine group (SK group) (d=0.5) CI 95% and power 80% the sample size was calculated to be 102,51 in each group. 3. Patients included in this study:
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent from 1st degree relative.
- •Physical ASA status I & II.
- •BMI less than or equal
- •Traumatic brain injury patients.
- •Age: ≥18 years old.
- •Sex: both sexes.
- •Paroxysmal sympathetic hyperactivity will be diagnosed on the basis of diagnostic criteria proposed by Blackman et al.(2), The signs of PAID syndrome include: (1) Severe brain injury (Rancho Los Amigos level IV), (2) temperature of at least 38.5°C, (3) pulse of at least 130 beats/min, (4) respiratory rate of at least 140 breaths/min, (5) agitation, (6) diaphoresis, and (7) dystonia (i.e. rigidity or decerebrate posturing). The duration is at least 1 cycle/day for at least 3 days
排除标准
- •1) Known hypersensitivity to study drugs. 2) Patients with primary brain stem injury or brain stem hemorrhage 3) Severe systemic organ diseases. 4) GCS score =3 points 5) Patients complicated with severe coagulation abnormalities, hemorrhagic shock, multiple organ failure.
- •6) Patients with a history of cerebral hemorrhage or cerebral infarction within the past 3 months. 7) Patients complicated with a history of end stage malignancy.
- •8) Patients complicated with a history of uncontrolled epilepsy.
研究组 & 干预措施
SD group
Stellate ganglion block and 1 ug/kg/h intravenous Dexmedetomidine infusion
干预措施: Stellate ganglion block (Procedure)
SD group
Stellate ganglion block and 1 ug/kg/h intravenous Dexmedetomidine infusion
干预措施: Dexmedetomidine (Drug)
SK group
Stellate ganglion block and 0.5 mg/kg/h intravenous ketamine infusion.
干预措施: Stellate ganglion block (Procedure)
SK group
Stellate ganglion block and 0.5 mg/kg/h intravenous ketamine infusion.
干预措施: Ketamine (Drug)
结局指标
主要结局
To compare the time of remission of neurostorm symptoms
时间窗: 6 months
Elevated blood pressure,tachycardia, fever and tachypenea of traumatic brain injury (TBI) between the stellate ganglion block combined with either dexmedetomidine or subanesthetic keyamine infusion
To assess effect of stellate ganglion block combined with either dexmedetomidine or subanesthetic ketamine infusion on changes in glascow coma scale score.
时间窗: 6 months
Daily evaluation of glascow coma scale score in which the lowest score is 3 ( indicates poor prognosis) and the highest is 15 (indicates the best prognosis)
次要结局
- ▪ To measure the duration of intensive care unit (ICU) stay.(6months)