Study of the Hypnotic and Anti-nociceptive Components of Magnesium Using Electroencephalogram Spectral Entropy and Pupillometry During Total Intravenous General Anaesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Propofol target concentration
研究概览
简要总结
The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.
详细描述
The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol. To achieve this, the investigators will analyse the effect of magnesium on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anaesthesia. Our study will also evaluate the intraoperative anti- nociceptive effect of magnesium using pupillometry and its two indices, PPI and PRD
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patient, anesthesiologist and surgeon are blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult > 18 years
- •Patients of both sexes
- •Any patient scheduled for thyroidectomy at the University Hospital of Liege
排除标准
- •Heart failure with left ventricular ejection fraction < 35
- •Renal insufficiency (clearance < 40 mL/min)
- •Neuromuscular diseases
- •Atrioventricular block
- •Pregnancy
研究组 & 干预措施
Magnesium sulfate IV
10 patients scheduled for thyroidectomy
干预措施: Magnesium sulfate IV (Drug)
Placebo
10 patients scheduled for thyroidectomy
干预措施: Placebo (Drug)
结局指标
主要结局
Propofol target concentration
时间窗: through study completion, an average of 3 months
The target concentration of Propofol TCI (target-control infusion) to achieve a state entropy value between 50-60
次要结局
- Morphine consumption(through study completion, an average of 3 months)
- PPI Measure(through study completion, an average of 3 months)
- PRD Measure(through study completion, an average of 3 months)
研究者
Jean François Brichant
Head of Anesthesiology Departement
University of Liege