Control of Emergence Hypertension After Craniotomy: Comparison Between the Efficacy of Magnesium Sulphate and Lidocaine Infusion (Randomized Controlled Study)
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- postcraniotomy emergence hypertension response to the study drugs
研究概览
简要总结
Post-craniotomy emergence hypertension is a common phenomenon that may predispose to development of intracranial hematoma and cerebral edema.The aim of this study is to compare the safety and efficacy of Mgso4 versus lidocaine infusion for control of emergence hypertension after craniotomy.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status Ι or Π.
- •scheduled patients for brain tumor excision.
排除标准
- •Hepatic, renal, cardiac, pulmonary, or endocrine impairment.
- •Signs of increased intracranial pressure or allergy to any of the used drugs.
研究组 & 干预措施
Magnesium sulphate
50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion
干预措施: Magnesium sulphate (Drug)
lidocaine hydrochloride
1.5mg/kg loading followed by 2mg/kg/hr infusion
干预措施: Lidocaine Hydrochloride (Drug)
NaCl 0.9% normal saline
Normal saline infusion with the same rate as the study drugs
干预措施: Normal saline (Drug)
结局指标
主要结局
postcraniotomy emergence hypertension response to the study drugs
时间窗: 4hours
The number of the patients who have systolic blood pressure below 140 mmH during emergence of anesthesia after craniotomy for brain tumors in each group
次要结局
- Recovery time(2 hours)
- Incidence of side effects of the used drugs(4 hours)
研究者
Ahmed Mohamed ELbadawy
Ahmed Mohamed ELbadawy- Clinical investigator , Cairo University
Kasr El Aini Hospital