The Bolus Dose of Dexmedetomidine (ED50) That Avoids Hemodynamic Compromise in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Dose of dexmedetomidine
研究概览
简要总结
Dexmedetomidine is a sedative drug that has many benefits when given to children under anesthesia, such as improved pain relief and reduced agitation following their surgery. It is usually given as an intravenous infusion over 10 minutes, to avoid the changes in heart rate and blood pressure that are occasionally seen when it is administered more quickly. However, this is often infeasible and usually inconvenient. The investigators aim to determine the dose of dexmedetomidine that can be given rapidly (over 5 seconds) without causing significant changes in heart rate and blood pressure. This will be the only study specific intervention.
详细描述
Purpose This study is being conducted to determine the dose of dexmedetomidine that can be given as a rapid bolus (over 5 seconds) following induction of anesthesia and insertion of a laryngeal mask airway (LMA) without causing significant hemodynamic compromise in healthy children.
Hypothesis We hypothesize that a rapid bolus of dexmedetomidine does not cause significant hemodynamic effects in healthy children.
Justification Dexmedetomidine given in a single peri-operative bolus without subsequent infusion has been shown to be beneficial. It would be arguably more practical to administer the dose as a rapid bolus. The hemodynamic effects of this have not been previously studied in healthy ASA I-II children (aged 5-10 years).
Objectives The objective of this study is to determine the dose of dexmedetomidine that can be given as a rapid bolus in healthy children following induction of total intravenous anesthesia (TIVA) without causing significant hemodynamic compromise.
Research Method This is a prospective, sequential design study using the up-and-down method (UDM) to determine the dose of dexmedetomidine that will prevent hemodynamic compromise following a rapid bolus in healthy children. The only study specific intervention will be a bolus of dexmedetomidine following induction of TIVA and insertion of an LMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I-II patients
- •Elective surgery
- •Planned general anesthesia with TIVA
- •Planned insertion of LMA
- •Ages ≥ 5 to < 10 years
排除标准
- •Cardiac disease
- •Cardiac rhythm abnormalities
- •Chronic hypertension
- •Predicted difficult intubation
- •Contraindication to LMA use
- •Weight < 5th centile or > 95th centile for age
- •Pre-operative administration of anxiolytics (such as benzodiazepines or opioid analgesics)
- •Hypersensitivity to dexmedetomidine or any other study medication
研究组 & 干预措施
Dexmedetomidine Rapid Bolus
All subjects will receive a rapid bolus of dexmedetomidine following induction of anesthesia with propofol and remifentanil and placement of laryngeal mask airway.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Dose of dexmedetomidine
时间窗: 10 minutes for each patient
Dose of dexmedetomidine that can be given as a rapid bolus that does not cause significant hemodynamic effects in healthy children
次要结局
- BIS readings(10 minutes for each patient)
研究者
Carolyne Montgomery
Principle Investigator
University of British Columbia