Efficacy of Propofol Versus Dexmedetomidine To Prevent Emergence Agitation After Sevoflurane Anesthesia In Children Undergoing Squint Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the overall incidence of postoperative Emergence Agitation
研究概览
简要总结
The goal of this clinical trial is to compare Propofol versus Dexmedetomidine in children undergoing squint surgery. The main question it aims to answer is:
• Which drug is more effective in preventing the appearance of Emergence Agitation in children after sevoflurane anesthesia in squint surgery, propofol or dexmedetomidine?
Emergence agitation (EA) is a period of restlessness, agitation, inconsolable crying, disorientation, delusions, and hallucinations with impaired cognition and memory that commonly occurs in children undergoing ophthalmic surgery especially after Short acting volatile agents such as sevoflurane.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients from 3 to 7 years.
- •American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
- •Patients undergo squint surgery.
排除标准
- •Declining to give written informed consent by patient legal guardian.
- •Age younger than 3 years or older than 7 years.
- •ASA classification ≥ III.
- •History of allergy to the medications used in the study or egg products.
- •Psychiatric disorder
- •Other co-morbidities or congenital anomalies or neurological.
研究组 & 干预措施
Group 1: Propofol group
children will be randomized to receive propofol 1mg/kg over 10 minutes
干预措施: Propofol (Drug)
Group 2: Dexmedetomidine group
children will be randomized to receive dexmedetomidine 0.2 mcg/kg over 10 minutes
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the overall incidence of postoperative Emergence Agitation
时间窗: EA incidence and severity will be determined using (PAED) scale at extubation (E0), upon arrival to the Post Anesthesia Care Unit (PACU) E1 and after 15 minute (E2), then after 30 minute in the PACU (E3).
Pediatric Anesthesia Emergence Delirium (PAED) scale will be use to assess the incidence of Emergence Agitation (EA) A PAED score of 10 or higher is considered to be diagnostic of EA, but a score of 12 or higher is more sensitive and specific.
次要结局
- heart rate changes(30 minutes in the PACU)
- mean arterial pressure (MAP) changes(30 minutes in the PACU)
- peripheral oxygen saturation (SpO2) changes(30 minutes in the PACU)
- Proportion of patients with adverse events in the PACU(assessed up to 30 minutes after arrival of patient to PACU.)
- Proportion of patients with Post Operative Nausea and Vomiting (PONV)(assessed up to 30 minutes after arrival of patient to PACU.)
- Time to discharge from the PACU.(60 minutes)