Half Effective Dose of Remimazolam to Prevent Cardiovascular Response to Tracheal Intubation When Combined With Fentanyl
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- half effective dose for intubation
研究概览
简要总结
Remimazolam has demonstrated the potential as a valuable medication for procedural sedation and general anesthesia. However, half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl in pediatric patients is still unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 3 to 12 years old
- •patients scheduled for surgery under general anesthesia
- •Body mass index in the range of 5% -95% of the same age group
- •Consent was obtained from the patient and the family members, and an informed consent form was signed
排除标准
- •American Society of Anesthesiologists status ≥3
- •patients who cannot cooperate with intravenous anesthesia induction
- •patients with risk of difficult airway
- •patients who are allergic to benzodiazepines
- •patients with neurological dysfunction
- •Participate involved in other clinical investigators within 3 months
研究组 & 干预措施
remimazolam
Remimazolam is given for anesthesia induction. The initial dosage is 0.4mg/kg, and the interval dosage is 0.02mg/kg.
干预措施: Remimazolam (Drug)
结局指标
主要结局
half effective dose for intubation
时间窗: from injection of remimazolam to completed tracheal intubation, at an average of 5 minutes
half effective dose of remimazolam required to prevent cardiovascular response to tracheal intubation when combined with fentanyl
cardiovascular response to tracheal intubation
时间窗: from injection of remimazolam to 3 minutes after tracheal intubation, at an average of 8 minutes
cardiovascular response is defined as increase of blood pressure or heart rate higher than 20% of the baseline value by 3 minutes after intubation
次要结局
- the time to loss of consciousness(from injection of remimazolam to loss of consciousness, at an average of 3 minutes)
- incidence of adverse events(from injection of remimazolam to loss of consciousness, at an average of 3 minutes)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China