The Effect of Small-dose Ketamine on Depression of Respiratory and Cardiac Functions Caused by Propofol in Pediatric Cardiac Catheterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- difference of partial pressure of arterial carbon dioxide between the groups
研究概览
简要总结
Normal cardiac and respiratory functions should be maintained during pediatric cardiac catheterization. Propofol has become a popular choice for sedation in children, however, it depresses cardiac and respiratory functions. Some investigators reported that ketamine attenuates its depressant effect, but it remains unclear whether ketamine reduces cardiac and respiratory depression caused by propofol in pediatric cardiac catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •7kg-25kg (6mo-10yrs) children who undergo cardiac catheterization
排除标准
- •patients who have neurological disease,
- •endocrinological disease,
- •airway anomaly, who require positive pressure ventilation
研究组 & 干预措施
control
propofol and saline are administered
干预措施: control (Drug)
Ket10
ketamine is co-administered with propofol
干预措施: Ket10 (Drug)
Ket20
ketamine is co-administered with porpofol
干预措施: Ket20 (Drug)
结局指标
主要结局
difference of partial pressure of arterial carbon dioxide between the groups
时间窗: 60 min after anesthetic induction on average
difference of end tidal partial pressure of carbon dioxide between the groups
时间窗: 30 and 60 min after anesthetic induction
heart rate change from baseline value
时间窗: 30 and 60 min after anesthetic induction
non-invasive blood pressure change from baseline value
时间窗: 30 and 60 min after anesthetic induction
次要结局
- movement at topical anesthetic injection(20 min after anesthetic induction on average)
- the number of times that secreted saliva is aspirated by an attending anesthesiologist(From anesthetic induction to termination of anethetics administration, which is not over 2 hours from anesthetic induction)
研究者
Kazuhiko Okuyama, MD
Head of Anesthesiology department
Ibaraki Children's Hospital