Evaluation of Preoperative Melatonin on Emergence Agitation After Herniorrhaphy Surgeries in Pediatrics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- emergence behaviour
研究概览
简要总结
efficacy of melatonin premedication on emergence agitation in children undergoing herniorrhaphy surgeries
详细描述
Before administration of the oral premedication, each patient's baseline heart rate, mean systemic arterial pressure, pulse oximetry, and sedation score (yale preoperative score) will be recorded All the anesthetic and surgical techniques will be standardized. On arrival at the operating room, continuous electrocardiogram, non-invasive blood pressure and pulse oximetry monitors will be applied. Baseline readings of all the parameters will be recorded.
Sevoflurane 3-8 MAC will be used for induction of anaesthesia. While intravenous line is inserted, atropine 0.01 mg/kg, atracurium 0.0.05 mg/kg is given. Anaesthesia maintainance done by 1.5-2 MAC sevoflurane. At the end of operation discontinuation of inhalational anesthesia will be done and muscle relaxant will be reversed by neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Then children were transferred to recovery till complete recovery Parameters assessed are induction time (IT) time from the start of sevoflurane inhalation to the start of endtracheal tube insertion, duration of anesthesia (DA) time from the start of sevoflurane inhalation to discontinuation of sevoflurane inhalation, time up to spontaneous eye opening (time from removal of endotracheal tube till spontaneous eye opening), duration of stay in recovery and any side effects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •scheduled for unilateral inguinal herniorrhaphy
- •parents conscent
排除标准
- •allergy to this study drug
- •Patients with a history of cardiovascular, psychiatric, neurological, endocrine, chest disease, and/or severe renal or hepatic dysfunction
研究组 & 干预措施
2
39 participant will receive melatonin 0.2 mg/kg
干预措施: Sevoflurane (Drug)
1
39 participant will receive melatonin 0.05 mg/kg
干预措施: Melatonin 5 MG/15 ML Oral Solution 0.05 mg/kg (Drug)
1
39 participant will receive melatonin 0.05 mg/kg
干预措施: Sevoflurane (Drug)
2
39 participant will receive melatonin 0.2 mg/kg
干预措施: Melatonin 5 MG/15 ML Oral Solution 0.2mg/kg (Drug)
3
39 participant will receive melatonin 0.4 mg/kg
干预措施: Melatonin 5 MG/15 ML Oral Solution 0.4mg/kg (Drug)
3
39 participant will receive melatonin 0.4 mg/kg
干预措施: Sevoflurane (Drug)
结局指标
主要结局
emergence behaviour
时间窗: 5 min, 15 min and 30 min after arrival to recovery
change from baseline on a 5 point scale
次要结局
- yale preoperative anxiety scale(before administration of oral premedication and before anaesthesia induction)
研究者
mostafa saieed fahim mansour
lecturer
Menoufia University