Comparison of Magnesium Sulphate 30 mg/Kg With Lidocaine 1,5 mg/Kg in Hemodynamic Changes and Cortisol Level Post-intubation in Patient Undergoing Craniotomy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The sample was randomly divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. These groups will be checked for hemodynamic changes and cortisol values.
详细描述
The sample was randomly divided into 3 groups and divided into 3 groups consisting of patients who received Magnesium Sulfate 30 mg/Kg, Lidocaine 1.5 mg/Kg, and Control. The first group of patients was given Magnesium Sulfate 30 mg /kg diluted in 20 ml with NaCl 0.9%, labeled with code A, and given in 5 minutes with a syringe pump, The second group was given Lidocaine 1.5 mg/kg diluted in 20 ml with NaCl 0.9%, labeled with code B and given in 5 minutes with a syringe pump, The third group was given NaCl 0.9%, in a 20 ml syringe labeled with code C and given in 5 minutes with a syringe pump. After induction and intubation, patients were then recorded systolic blood pressure, diastolic blood pressure, MAP, and pulse at T1 (3 minutes), T2 (5 minutes), T3 (7 minutes), and T4 (10 minutes).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
盲法说明
masks the subjects and care provider from knowing which study treatment
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
- 是
入选标准
- •patients aged 18-65 years;
- •body mass index (BMI) 18.5 kg/m2 - 29.9 kg/m2;
- •patients or their families agreed to be used as research subjects;
- •elective non-traumatic craniotomy cases, namely supratentorial brain tumor evacuation, intracerebral hemorrhage evacuation, subdural hemorrhage, cerebrovascular correction.
排除标准
- •cardiac, hepatic, and renal disorders;
- •patients with pregnancy;
- •hypertension or hypotension before surgery;
- •hypersensitivity to Magnesium Sulfate and/or Lidocaine;
- •patients with chronic use of corticosteroid drugs, calcium channel blockers, magnesium-containing drugs, and opioids;
- •risk of difficult intubation and ventilation according to the LEMON score and MOANS score criteria;
- •impaired cortisol secretion (pituitary tumor or hypothalamic tumor or adrenal gland disorder); and
- •patients with hypocortisol or hypercortisol at T0 serum cortisol examination.
研究组 & 干预措施
MgSO4 intravenous
Sample will be given MgSO4 30mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
干预措施: Magnesium Sulfate 20 MG/ML (Drug)
Lidocaine intravenous
Sample will be given Lidocain 1.5mg/Kg Intravenous as a premedication drugs before intubation for all patients who had craniotomy surgery
干预措施: Lidocaine IV (Drug)
NaCl 0,9% Intravenous
Sample will be given NaCl 0,9% Intravenous 20 ml as a premedication drugs before intubation for all patients who had craniotomy surgery
干预措施: saline solution (Drug)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 1 month
mmHg
Diastolic Blood Pressure
时间窗: 1 month
mmHg
Mean Arterial Pressure (MAP)
时间窗: 1 month
Estimated by using a formula in which the lower (diastolic) blood pressure is doubled and added to the higher (systolic) blood pressure and that composite sum then is divided by 3 to estimate MAP
Heart Rate
时间窗: 1 month
beats per minute
次要结局
- Cortisol Levels(1 month)
研究者
Arsil Radiansyah
Resident Doctor
Universitas Sumatera Utara