Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries: A Randomized Controlled Study.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups.
研究概览
简要总结
The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery, in comparison to dexmedetomidine.
详细描述
To compare the incidence of ED between children who received ketofol with those who received dexmedetomidine.
• To compare the adverse effect profile associated with both drugs regarding the effect on heart rate, mean arterial pressure, recovery time, nausea, and vomiting.
Hypothesis
We hypothesize that Ketofol, due to the combined effect of ketamine and propofol will be as effective as dexmedetomidine in preventing ED in pediatric patients undergoing squint surgery.
Ethical Considerations
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• All pediatric patients aged 2 to 6 years.
- •Both sexes.
- •ASA physical status I and II.
- •Patients undergoing squint surgery.
排除标准
- •• Refusal of parents.
- •Patient sensitivity to any of the study medications.
- •Known neurological disease that can affect the assessment of ED postoperatively.
研究组 & 干预措施
Ketofol Group
Five minutes after induction; Ketofol (ketamine to propofol ratio 1:4) will be infused at a rate of 0.6 ml/kg/hr. Ketofol will be prepared by adding 40 mg of ketamine to 160 mg of propofol and diluted to 20 ml with normal saline 0.9%.
干预措施: Ketamine (Drug)
Dexmedetomidine
Five minutes after securing the airway, dexmedetomidine infusion will be started at a rate of 0.2 mcg/kg/hr.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
The incidence of postoperative ED using PAED scale at time of admission to PACU in both groups.
时间窗: PAED score immediately after admission to PACU .
During their stay at PACU, delirium will be assessed at 5, 10, 15, 20, 25, and 30 minutes following extubation via the Pediatric Anesthesia Emergence Delirium scale (PAED) . ED will be established when the child have a score of 10 or more. If the child has a score of 10 or more, rescue sedation will be done via propofol 1 mg/kg .
次要结局
未报告次要终点
研究者
Muhammad Khalaf
principle investigator
Cairo University