Anesthetic Sparing Effect of Dexmedetomidine During TIVA With Propofol and Remifentanil for Children Undergoing Dental Procedures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Propofol and remifentanil sparing
研究概览
简要总结
The investigators propose to determine the propofol and remifentanil sparing effects of a single dose of dexmedetomidine in the dental population. The investigators plan to do this by performing a blinded study with 4 test groups (3 experimental and 1 control), using BIS monitoring to titrate TIVA infusion to an acceptable depth of anesthesia.
详细描述
Purpose:
To determine an optimal dose of dexmedetomidine for its anesthetic sparing effect, without extending post-operative stay.
Hypothesis:
The investigators hypothesize that dexmedetomidine will cause a clinically significant reduction of 30% in the amount of propofol and remifentanil required to maintain adequate depth of anesthesia, as monitored through the Bispectral Index.
Justification:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessor of sedation scores post-procedure will be blinded to group allocation.
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective dental surgery
- •Planned general anesthesia with TIVA
- •Age 2-10 years
排除标准
- •General anesthesia with inhalation induction
- •Documented seizure disorder
- •Cardiac disease
- •Cardiac rhythm abnormalities
- •Chronic hypertension
- •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
Saline bolus
10mL normal saline solution administered intravenously over 60 seconds starting after intubation.
干预措施: Normal saline (Drug)
Dexmedetomidine 0.25 mcg/kg
0.25 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 0.50 mcg/kg
0.50 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine 1.00 mcg/kg
1.00 mcg/kg dexmedetomidine diluted with normal saline to a 10mL volume, administered intravenously over 60 seconds starting after intubation.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Propofol and remifentanil sparing
时间窗: Through length of procedure, an average of 1.5 hours
Propofol and remifentanil sparing as measured by time-averaged, total administered doses of propofol (mg/kg) and remifentanil (mcg/kg) compared to the placebo group.
Propofol and remifentanil infusion rate reduction
时间窗: Through length of procedure, an average of 1.5 hours
Change in infusion rates of propofol and remifentanil (in micrograms/kg/min), measured over time compared to the placebo group.
次要结局
- PACU sedation(30min post-procedure)
- PACU pain scores(30min post-procedure)
研究者
Simon Whyte
Principal Investigator
University of British Columbia