The Role of Gabapentin Oral Solution in Decreasing Desflurane Associated Emergence Agitation and Delirium in Children After Strabismus Surgery: A Prospective Randomized Double-blind Study
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- emergence agitation incidence and scores
研究概览
简要总结
to study the effect of oral gabapentin (5 mg/kg) on emergence agitation after desflurane anesthesia in pediatrics undergoing starbismus surgery
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •pediatric patients (2-6 years old), with an American society of Anesthegiologists physical status (ASA) I-II who were undergoing strabismus surgery (for more than one muscle)
排除标准
- •failure to obtain consent, mental retardation or developmental delay, epilepsy, psychiatric or neurological diseases that impair communication, current use of gabapentin, psychotropic or opioids.
研究组 & 干预措施
Control group
patients received strawberry juice 5 ml volume, one hour before induction.
干预措施: Strawberry juice as (placebo) (Drug)
Gabapentin group
patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.
干预措施: Gabapentin Oral Solution [Neurontin] (Drug)
结局指标
主要结局
emergence agitation incidence and scores
时间窗: through study completion, an average of 1 year
agitation measured by emergence agitation scale: \[1= Obtunded with no response to stimuli; 2= Asleep, but responsive to movement and stimuli; 3= Awake and appropriately responsive; and 4= Crying and difficult to console; 5= Wild thrashing behaviour that requires restraint\]. A score 4 or 5 was considered as agitation and was treated by IV meperidine 0.5 -1 mg/kg increments.
次要结局
- duration of emergence(through study completion, an average of 1 year)
研究者
Ahmed A. Badawy
Anesthesia Consultant
Kuwait Specialized Eye Center