Propofol-Ketamine vs. Propofol-Fentanyl for Sedation During Pediatric Diagnostic Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- incidence of desaturation
研究概览
简要总结
comparison between propofol-fentanyl and propofol-ketamine for sedation in pediatric diagnostic gastrointestinal endoscopy.
详细描述
It is a prospective double blinded controlled study that will be carried out on 60 pediatric patients undergoing GIT endoscopy; they will be divided into two groups of 30 patients each:- Group I (PF): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV. Group II (KF): will receive Ketofol (1 ketamine: 4 propofol) 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients undergoing diagnostic GIT endoscopy
排除标准
- •Emergency endoscopy
- •Respiratory infection and hyperactive airways
- •History of serious adverse effects related to anesthetics (e.g. allergic reactions), a family history of reactions to the study drugs
- •Morbid obesity, and neuropsychiatric disorders
研究组 & 干预措施
Fentanyl
Group I (FP): will receive 0.5 µg/ kg fentanyl + 2 mg/ kg propofol IV.
干预措施: Fentanyl (Drug)
Ketamine
Group II (KP): will receive 0.5 mg/kg ketamine + 2 mg/kg propofol IV.
干预措施: Ketamine (Drug)
结局指标
主要结局
incidence of desaturation
时间窗: up to 2 days after operation
when oxygen saturation below 90%
次要结局
未报告次要终点
研究者
Mohamed galal aly
Assistant Professor
Assiut University