Effect of Dexmedetomidine Versus Magnesium Sulfate Infusion on Intracranial Pressure and Cerebral Perfusion Pressure in Craniotomy Using Lumbar Drain Catheter
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change in ICP and CPP in craniotomy
研究概览
简要总结
To compare the intraoperative effects of Dexmedetomidine and Magnesium Sulfate infusion on intracranial pressure and cerebral perfusion pressure in adult patients undergoing craniotomy
详细描述
Intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are critical parameters in craniotomy patients . Effective modulation of these pressures during surgery can improve intraoperative stability and postoperative recovery . Dexmedetomidine (Dexamed) is a selective α2-adrenoceptor agonist with sedative and neuroprotective properties, known to reduce ICP without respiratory depression . Magnesium Sulfate (MgSO₄) acts as an NMDA receptor antagonist and vasodilator, promoting neuronal protection and improved cerebral blood flow . By using a lumbar drain catheter intraoperatively, direct and continuous measurement of ICP is feasible, offering real-time insight into the pharmacological effects of these agents on cerebral dynamics .
The underlying research question is as follows: Can intraoperative Dexmedetomidine as opposed to Magnesium sulfate result in better ICP and CPP management of adult craniotomy patients? Nonetheless, the individual basis of usage of Dexmedetomidine and Magnesium Sulfate in neurosurgeries has been supported by existing literature , but lack of direct comparative studies to determine the effects of the two drugs on real-time intracranial and cerebral perfusion pressure in the craniotomy . This study aims to fill the existing gap in the literature by stating the continuity of ICP monitoring with a lumbar drain, thus offering a robust and standard control environment of comparison.
Intervention Protocol
Participants will be randomly assigned to one of two groups:
Group A - Dexmedetomidine Infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Elective craniotomy for supratentorial pathology
- •No contraindication to lumbar drain insertion
- •Baseline mental status is stable, allowing for a reliable postoperative neurological evaluation can be done
- •ASA physical status I-III
排除标准
- •Coagulopathy or current anticoagulation
- •Severe renal or hepatic dysfunction
- •Known allergy to study medications
- •traumatic brain injury
研究组 & 干预措施
Dexmedetomidine
Dexmedetomidine: loading dose 1 µg/kg IV over 10 min after induction and then maintenance dose 0.2- 0.7 µg/kg/hr based on hemodynamic response
干预措施: Dexamedomedine (Drug)
Mgso4
Magnesium Sulfate: Used as an IV loading dose at 20 mg/kg IV over 17 minutes as an induction agent, followed by maintenance of 10 mg/kg/h to skin closure.
干预措施: MgSO4 (Drug)
结局指标
主要结局
Change in ICP and CPP in craniotomy
时间窗: o Pre-loading o After loading o Once the patient is in position (other than baseline) o After 30 min of incision (or every 30-60 min till skin closure)
compare the intraoperative intracranial pressure (ICP) and cerebral perfusion pressure (CPP) effects of dexmedetomidine and magnesium sulfate infusion in a comparative study to determine the efficacy in adult patients undergoing craniotomy, continuous measurement was achieved with the help of a lumbar drain catheter.
次要结局
未报告次要终点
研究者
Hassan mostafa abdelbaky ahmed
Assistant lecturer
Assiut University