The Effects of Dexmedetomidine on Myocardial Repolarization in Children
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention
研究概览
简要总结
Dexmedetomidine is a sedative drug that is commonly used to improve calmness and reduce pain in children waking up after surgery. Some of the side effects of dexmedetomidine, such as a potential change in how the heart muscles contract and changes in blood sugar and potassium levels, are poorly understood. The current study aims to examine these changes directly in healthy children undergoing elective surgery by measuring the heart beats (with an electrocardiogram) and blood sugar and potassium at specific times before and after dexmedetomidine is given. The investigators aim to establish a better understanding of this drug's safety profile.
详细描述
Purpose:
This study is being conducted to evaluate the effect of three different doses of dexmedetomidine (Precedex® , Hospira Healthcare) on myocardial repolarization, and blood glucose and potassium levels in children undergoing elective surgery.
Hypotheses:
The investigators hypothesize that administering a dexmedetomidine bolus will have some effect on myocardial repolarization, blood glucose, and potassium concentrations in a dose-dependent manner, whereas a saline bolus will not.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
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
- •ASA Physical Status I-II
- •Age 3 to 10yrs
- •Elective surgical procedure requiring general anesthesia
- •Use of dexmedetomidine acceptable to the staff anesthesiologist
- •Un-premedicated
- •Ability to read and understand English (parent/legal guardian(s) and child)
排除标准
- •Long QT syndrome (LQTS)
- •Cardiac disease or rhythm abnormalities
- •Family history of LQTS or abnormal cardiac conduction
- •Currently taking medications known to prolong QT
- •Currently taking medications known to predispose to hypokalemia
- •Known hypersensitivity to dexmedetomidine or other study medication
- •Weight < 5th centile or > 95th centile for age
- •Previously diagnosed hypokalemia
- •Impaired renal or liver function
- •Pre-operative anxiety requiring sedatives or opioids
- •Refusal to participate
研究组 & 干预措施
Dexmedetomidine 0.25mcg/kg
0.25mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.5mcg/kg
0.5mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.75mcg/kg
0.75mcg/kg dexmedetomidine diluted with normal saline in a 10mL syringe, administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
干预措施: Dexmedetomidine (Drug)
Saline bolus
10mL normal saline solution administered intravenously over 60 seconds starting 3 minutes after induction of anesthesia.
干预措施: Saline (Drug)
结局指标
主要结局
Myocardial Repolarization (QTc and TP-e Intervals) 1min After Intervention
时间窗: 60 seconds post-intervention
Absolute QTc and TP-e values 1min after a bolus of dexmedetomidine or saline. Measured with 12-lead ECG.
次要结局
- Blood Potassium Levels at 15min and 30min Post-intervention(over 30 minutes post-intervention)
- Blood Glucose Levels at 15min and 30min Post-intervention(over 30 minutes post-intervention)
研究者
Simon Whyte
Principle Investigator
University of British Columbia