Bispectral Index Guiding Etomidate Used in Children Aged 3 to 10 for Clinical Anesthesia Induction
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 主要终点
- the amount of drugs
研究概览
简要总结
This research through using bispectral index to guide the induced dose and speed of etomidate lipid emulsion for pediatric total venous anesthesia,and to provide a reference for clinical anesthesia physician.
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
- None
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •obtain informed consent;
- •undergoing elective hypospadias repair surgery under general anesthesia;
- •American society of anesthesiologists (ASA) class I-II;
- •aged between 3-10 years old;
- •BMI is 18.5-30 kg/m2;
排除标准
- •systolic blood pressure≥180 mmHg or<90 mmHg, diastolic blood pressure≥110 mmHg or<60 mmHg;
- •serious heart, brain, liver, kidney, lung, endocrine diseases or serious infections;
- •long-term use of hormone or a history of adrenal cortex inhibition;
- •suspected or confirmed difficult airway;
- •suspected or confirmed abuse of narcotic analgesic drugs, psychotropic drugs;
- •neuromuscular disease;
- •mental instability, or have a mental illness;
- •allergic to investigational products or with other contraindication
- •participated in other study within 30 days
研究组 & 干预措施
etomidate group
infusion of etomidate at 2 minutes before anesthesia induction
干预措施: etomidate (Drug)
propofol group
infusion of propofol at 2 minutes before anesthesia induction
干预措施: propofol (Drug)
sevoflurane group
inhale sevoflurane for anesthesia induction and maintenance
干预措施: sevoflurane (Drug)
结局指标
主要结局
the amount of drugs
时间窗: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
the amount of etomidate,propofol and sevoflurane used in anesthesia induction
the drugs used time
时间窗: from the beginning of induction to Bispectral Index < 50,expected to be within 1 minute
the injection time of etomidate and propofol, and the inhale time of sevoflurane during anesthesia induction
numbers of muscular fibrillation
时间窗: from the beginning of induction to Bispectral Index < 50,up to 5 minutes
numbers of muscular fibrillation in anesthesia induction
degree of inflammation reaction
时间窗: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
serum levels of interleukin 6 and tumor necrosis factor α will be measured at each time point using ELISA method
adrenal function
时间窗: baseline,5 minutes after indution,5 minutes before operation end,30 mimutes、24h and 48h after operation
serum level of cortisol will be measured at each time point using radioimmunoassay
次要结局
- hemodynamic parameters(from the beginning of induction to skin closure, up to 3 hours)
- sedation degree(from the beginning of induction to skin closure, up to 3 hours)