Optic Nerve Sheath Diameter (ONSD): A New Modality to Assess Postoperative Agitation After a Single Bolus of Dexmedetomidine Versus Normal Saline in Children With Cleft Palate Repair
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- the Pediatric Anesthesia Emergence Delirium (PAED) score
研究概览
简要总结
The hypothesis of this study is to investigate and compare the efficacy between the administrations of single intravenous (IV) dose of dexmedetomidine versus normal saline in preventing immediate postoperative agitation in children undergoing cleft palate repair.
详细描述
A written informed consent will be taken from the guardian of children.Patients will be assigned randomly to three groups (30 subjects each) to be anesthetized. The study drug will be delivered in opaque bags labeled "study drug" and 90 patients will be allocated in three groups (of 30 patients each) to receive the study drug at the end of surgery; a single dose of 0.5 µ/kg IV dexmedetomidine (Group D) or same volume of saline placebo (Group C).
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, Care Provider)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (age 1-7 years) of American Society of Anaesthesiologists physical status (ASA) I-II
- •Elective cleft palate repair ± cleft lip surgery under general anesthesia.
排除标准
- •Ventriculo-peritoneal shunt
- •Suspected meningitis
- •Congenital hydrocephalus
- •Clinical signs of suspected increased intracranial pressure
- •On treatment for seizures or metabolic diseases
- •Children with developmental delay
- •Hypersensitivity to dexmedetomidine or nalbuphine
研究组 & 干预措施
Group C
Same volume of saline placebo IV at the end of surgery
干预措施: 0.9% saline (Other)
Group D
Dexmedetomidine IV at the end of surgery
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
the Pediatric Anesthesia Emergence Delirium (PAED) score
时间窗: 1 hour postoperative
Emergence delirium (ED) will be measured by the Pediatric Anesthesia Emergence Delirium (PAED) scale. The scores for each of the five listed behaviours (The child makes eye contact with the caregiver/parent, the child's actions are Purposeful, the child is aware of his/her surroundings, the child is restless and the child is inconsolable) are added to achieve a total score (maximum score of 20). A score of ≥ 12 yields 100% sensitivity and 94.5% specificity for the diagnosis of ED
次要结局
- FLACC (Face, Legs, Activity, Cry, and Consolability) pain score.(1 hour postoperative)
研究者
Omar Makram Soliman
Lecturer of anesthesia and ICU
Assiut University