Nebulized Versus Intravenous Dexmedetomidine for Managing Sevoflurane Induced Emergence Agitation After Pediatric Tonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
研究概览
简要总结
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I and II
- •Children scheduled for tonsillectomy with or without adenoidectomy with or without myringotomy, and/or tympanostomy tube insertion.
排除标准
- •Patient's guardian refusal to participate in the study.
- •Children with Behavioral changes; physical or developmental delay; neurological disorder or psychological disorder.
- •Children on sedative or anticonvulsant medication.
- •history of sleep apnea
- •significant organ dysfunction, cardiac dysrhythmia, congenital heart disease
- •Known allergy to the study drugs.
研究组 & 干预措施
Nebulized Dexmedetomidine
Children will receive a nebulized dexmedetomidine 2 mic/ kg diluted in 3 ml of 0.9% saline 1 h before induction of anaesthesia.
干预措施: Nebulized Dexmedetomidine (Drug)
Intravenous Dexmedetomidine
Children will receive intravenous (IV) dexmedetomidine 1mic/kg diluted in 10 ml of 0.9% saline over 10 minutes after anesthesia induction.
干预措施: Intravenous Dexmedetomidine (Drug)
结局指标
主要结局
postoperative Emergence agitation will be evaluated using the Paediatric Anaesthesia Emergence Delirium scale
时间窗: 60 minutes
Paediatric Anaesthesia Emergence Delirium (PAED) scale will be used to evaluate emergence agitation upon admission to the PACU (0 min, baseline) and at 5, 10, 20, 30, 45, and 60 min until discharge from the PACU. The highest EA scores observed during this period will be recorded. PAED score ≥ 10 will be considered to be a diagnostic endpoint for the development of agitation.
次要结局
- emergence agitation (EA) onset(60 minutes)
- Emergence Agitation duration(60 minutes)
- Postoperative pain(60 minutes)
研究者
Ahmed Aboulfotouh Mohammed
lecturer of Anesthesia and icu
Assiut University