Dexmedetomidine Versus Magnesium Sulphate in Patients Undergoing Craniotomy for Deeply Settled Intracranial Tumours
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in brain relaxation score
研究概览
简要总结
An intracranial tumor, is an abnormal mass of tissue in which cells grow and multiply uncontrollably, seemingly unchecked by the mechanisms that control normal cells. More than 150 different brain tumors have been documented, but the two main groups of brain tumors are termed primary and metastatic.
Primary brain tumors include tumors that originate from the tissues of the brain or the brain's immediate surroundings.
Metastatic brain tumors include tumors that arise elsewhere in the body (such as the breast or lungs) and migrate to the brain, usually through the bloodstream Barbiturates, Thiopental and pentobarbital decrease CBF, cerebral blood volume (CBV), and ICP. The reduction in ICP with these drugs is related to the reduction in CBF and CBV coupled with metabolic depression. These drugs will also have these effects in patients who have impaired CO2 response.
Etomidate, as with barbiturates, etomidate reduces CBF, CMRo2, and ICP. Systemic hypotension occurs less frequently than with barbiturates. Prolonged use of etomidate may suppress the adrenocortical response to stress.
Dexmedetomidine as an anesthetic adjuvant improved hemodynamic stability and decreased anesthetic requirements in patients undergoing resection for brain tumors. In addition, DEX provided better surgical field exposure conditions and early recovery from anesthesia. Narcotics, in clinical doses, narcotics produce a minimal to moderate decrease in CBF and CMRo2. When ventilation is adequately maintained, narcotics probably have minimal effects on ICP. Despite its small ICP-elevating effect, fentanyl provides satisfactory analgesia and permits the use of lower concentrations of inhalational anaesthetics
详细描述
Anesthetic management:
Peripheral i.v line will be inserted and 2-3 mg midazolam is given. A pre-induction radial arterial line is inserted with the aid of infiltration of 2 ml lidocaine 2%. Invasive arterial blood pressure monitoring is started and pulse oximetry, 5-leads ECG, and NIBP are attached to the patient and mindray ipm-12 monitor is used. Anesthetic induction started with propofol 1-2 mg/kg, lidocaine 1 mg/kg, cis-atracurium 0.2 mg/kg and fentanyl 1-2 microgram/kg. Intubation is done with cuffed endotracheal tube and tidal volume and respiratory rate are set to achieve end-tidal Co2 of 30-28 mmHg. Esophageal temperature probe and urinary catheter are put in place. Patients then will receive maintenance of anesthesia with isoflurane < 1 MAC, propofol 10-60 microgram/kg/min, and cis-atracurium 2-3 microgram/kg/minute.
Patients are then grouped into two groups:
Group A: will receive dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery.
Group B: will receive 2 gm magnesium infusion for 30 minutes. All Patients will receive mannitol 20% 0.5-1 gm/kg and dexamethasone 8mg and paracetamol 1gm near the end of surgery. Patients will receive their fasting requirements of normal saline in the first 3 hours of surgery. Maintenance fluid used will be ringer acetate and will be given according to pulse pressure variation index (PPVI) that is derived from pulse contour analysis of invasive arterial blood pressure waveform. Patients will be given ringer acetate when PPVI is > 12%.
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
- Double (Participant, Outcomes Assessor)
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
- •American Society of Anesthesiologists (ASA) physical status I and II.
- •Age more than 18 years old.
- •supine Position
- •Patient undergoing craniotomy for deeply settled brain tumours.
排除标准
- •American Society of Anesthesiologists (ASA) physical status III or more and patients with GCS < 13
- •Other positions (prone position, lateral position)
- •Superficial brain tumors.
研究组 & 干预措施
A: Dexmedetomidine
Brain tumor excision under general anesthesia. This group will receive dexmedetomidine loading 1 microgram/kg bolus in 10 minutes followed by 0.2-1 microgram/kg/hour till the end of surgery.
干预措施: Dexmedetomidine (Drug)
B: Magnesium sulphate
Brain tumor excision under general anesthesia. This group will receive a 2 gm magnesium infusion for 30 minutes.
干预措施: Magnesium sulfate (Drug)
结局指标
主要结局
Change in brain relaxation score
时间窗: assessed by the neurosurgeon with dural opening, after 2 hours and before dural closure
On dural opening, brain relaxation score will be assessed which is a four points score 1. relaxed, 2. satisfactory, 3. firm, 4. Bulging
次要结局
未报告次要终点
研究者
Ibraheem Abdelmageed
Dr.Ibraheem Abdelmageed, lecturer of anaesthesia and intensive care at Assiut university
Assiut University