A randomised control study to compare two different methods of induction of anaesthesia in paediatric patients and its effect on emergence delirium.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) To measure and compare the incidence of agitation and delirium in paediatric patients after the recovery (i.e., after the discontinuation of anaesthesia) between two methods of induction of anaesthesia, IV induction with Ketamine and Inhalational induction with Sevoflurane using paediatric anaesthesia emergence delirium score.
研究概览
简要总结
Sevoflurane is generally the preferred anaesthetic agent for induction and maintenance of general anaesthesia in paediatric patients, including patients with extreme non-cooperation, due to its rapid induction and recovery characteristics. However, it has been recognized that one of the major complications after sevoflurane anaesthesia in paediatric patients is emergence agitation when awakening from general anaesthesia, with the reported incidence ranging between 10% and 80%.
Emergence agitation is recognized as a major risk factor for significant complications, such as anxiety, eating and sleeping disorders, and enuresis, along with persistent secondary alteration of emotional and cognitive development. Furthermore, the prolonged postoperative severe agitation might be another major complication for safety management of these patients. These have negative implications from a hospital management point of view, and also cause a decline in patient satisfaction and that of their families due to the potential for self-injury and other injurious behaviours, and are a burden on nursing staff.
As it is more stressful for both patients, parents as well as medical and nursing staff we have devised this study to evaluate whether any change in the technique of anaesthesia induction could possibly lower the incidence of ED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •Child with ASA PHYSICAL STATUS 1 and 2 of either Sex.
- •Age 2 to 12 years.
排除标准
- •Known allergies to the drugs used.
- •Child belonging to ASA III and above.
- •Child with a history of any Cardiovascular, respiratory, or central nervous system disorder.
- •Child with Neurological diseases, developmental delay, Airway difficulty.
结局指标
主要结局
1) To measure and compare the incidence of agitation and delirium in paediatric patients after the recovery (i.e., after the discontinuation of anaesthesia) between two methods of induction of anaesthesia, IV induction with Ketamine and Inhalational induction with Sevoflurane using paediatric anaesthesia emergence delirium score.
时间窗: To access the Emergence Delirium in the Paediatric Patients using Paediatric Anaesthesia Emergence Delirium Score at 0, 15, 30, 60 and 120 mins.
次要结局
- 1. To assess the ease of mask acceptance.(2. To compare the hemodynamic response between both the types of induction of anaesthesia.)