Comparison of Intranasal Midazolam or Dexmedetomidine on Epileptiform EEG During Sevoflurane Mask Induction in Children
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- incidence of epileptiform EEG
研究概览
简要总结
Induction with high sevoflurane concentrations may trigger epileptiform electroencephalographic activity without motor or cardiovascular manifestations in healthy patients. No other symptoms were associated in this series, and only electroencephalographic monitoring allowed the diagnosis. Midazolam and dexmedetomidine are sedatives commonly used in children before surgery. Although the mechanisms are different, both have been reported in antiepileptic effects.
This study was designed to compare the effects between intranasal midazolam or dexmedetomidine on epileptiform EEG during sevoflurane mask induction in children. Anaesthesia was induced with 8% sevoflurane. The patients were randomly assigned to Group A (n=15, preoperative intranasal normal saline), Group B (n=15, preoperative intranasal 0.25mg/kg midazolam), and Group C (n=15, preoperative intranasal 1μg/kg dexmedetomidine). An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status 1-2
- •Scheduled for general anesthesia
排除标准
- •Patients with a history of neurological, mental illnes
- •Patients with a history of congenital heart disease
- •Patients with a history of allergies to related drugs
研究组 & 干预措施
Group A
干预措施: Placebos (Drug)
Group B
干预措施: Midazolam (Drug)
Group C
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
incidence of epileptiform EEG
时间窗: 0 min after induction, up to 10 min
EEG were visually analyzed off-line by a neurophysiologist familiar with anesthesia EEG and blinded to the randomization. EEG abnormalities related to epileptic features were classified according to the description of Vakkuri and Jaaskelainen, and the recommendations of Constant: spikes and spikes with slow wave complexes (SW), rhythmic polyspikes corresponding to waveforms appearing at regular intervals (RPS) and periodic epileptiform discharge (PED), which refers to periodic hypersynchronized complexes occurring bilaterally. These entire electroencephalographic phenomena were considered as epileptiform EEG if their duration was longer than three seconds.
次要结局
- intubation time(0 min after intubation)
- electroencephalographic changes(0 min after induction, up to 10 min)
- hemodynamic changes(10 min after induciton)
研究者
Yu Sun
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University