Dexmedetomidine Augments Block of Sympathetic Responses to Skin Incision During Sevoflurane Anesthesia in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 主要终点
- the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
研究概览
简要总结
The study was designed to define the interaction of intravenous infusion of dexmedetomidine, an a2-adrenergic agonist, and sevoflurane in children having surgery by using the minimum alveolar concentration which can block adrenergic and cardiovascular responses to incision(MACbar) of sevoflurane as the measure of anesthetic potency.
详细描述
The investigators observed the effects of different doses of dexmedetomidine on the minimum alveolar concentration of sevoflurane to blockade adrenergic response to surgical incision in 50% of children (MACBAR). And to explore the safety of use of dexmedetomidine in pediatric patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 2 to 6 yr
- •American Society of anesthesiologists I or II
- •scheduled to have general anesthesia and to have skin incisions on the abdomen
排除标准
- •anemia or abnormal preoperative electrolyte concentrations
- •a history of cardiovascular or central nervous system diseases
- •a history of pulmonary disease
- •known hepatic or renal disease
- •a body weight exceeding 50% of the upper limit of ideal body weight for height
- •taking drugs with cardiovascular or central nervous system effects
- •use of any experimental drug within the past 30 days
- •allergy to any drug that may be administered during the study
- •exposure to general anesthesia within the previous 7 days
- •second- or third-degree atrioventricular block
- •taking drugs preoperatively that would interfere with MAC determination(e.g.,opioids or sedatives)
研究组 & 干预措施
D1 group
children undergoing selective lower abdominal surgery received a bolus dose of 0.5 µg/kg dexmedetomidine followed by a continuous infusion of 0.5 µg/kg /h before induction
干预措施: dexmedetomidine (Drug)
D2 group
children undergoing selective lower abdominal surgery received a bolus dose of 1.0µg/kg dexmedetomidine followed by a continuous infusion of 1.0 µg/kg /h before induction
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
the end-tidal sevoflurane concentration to blockade adrenergic response to surgical incision in 50% of children (MACBAR)
时间窗: at once before incision and 5 min period after incision
A predetermined steady-state end-tidal sevoflurane concentration(4%) was maintained for at least 15 min before skin incision.we observed the change in Mean Blood Pressure or Heart rate to determined the next end-tidal sevoflurane concentration.Followed the modified Dixon up and down method to obtain MACBAR of every child.The MACBAR of sevoflurane and its 95% confidence interval were calculated by Sum Average method.
次要结局
未报告次要终点
研究者
Cai Li
Department of Anesthesiology, First Affiliated Hospital, Sun Yat-Sen University
First Affiliated Hospital, Sun Yat-Sen University