Comparison of two doses of intravenous Dexmedetomidine on emergence agitation in paediatric patients undergoing inguinal hernia surgeries under general anaesthesia with sevoflurane
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- To compare the effect of two doses of Dexmedetomidine on the incidence of emergence
研究概览
简要总结
Emergence agitation is commonly seen in children during recovery from general anaesthesia.1
It is associated with symptoms such as combative movements, excitability, thrashing,
disorientation, inconsolable crying, and restlessness.
2 This behaviour results in anxiety, delayed
discharge from the post anesthestic care unit, and creates problems for parents as well as
caregivers.
3 It occurs for a short duration, but it may require pharmacological intervention,
resulting in a prolonged post-anesthesia care unit stay. As, the pathophysiology is unknown but
risk factors include preschool age, preoperative anxiety, postoperative pain, nausea, vomiting,
and inhalational anaesthetics specially sevoflurane.4
Dexmedetomidine is a highly potent and selective alpha-2 adrenoreceptor which has sedative,
anxiolytic, and analgesic properties without significant respiratory depression.
9 It has been used
effectively in intensive care to aid weaning from mechanical ventilation and now is being
utilized increasingly in paediatric anaesthesia.5 It has been used by various authors intranasally
and intravenously as a bolus and continuous intravenous (IV) infusion to suppress the incidence
of EA in various surgeries such as adenotonsillectomy, cleft lip & palate repair, and strabismus
correction.3,5,10 Limited literature is available regarding the lowest dose of Dexmedetomidine
for the prevention of emergency agitation in paediatric patients. Therefore, in this study, we are
planning to evaluate the effect of low dose of intravenous Dexmedetomidine on emergence
agitation in paediatric patients undergoing inguinal hernia surgeries under general anesthesia with sevoflurane
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 1-6 years fulfilling the criteria of American Society of Anesthesiologists physical status I and II undergoing inguinal hernia surgeries under general anaesthesia with sevoflurane will be included in the study.
排除标准
- •The patients with following history will be excluded from the study:
- •Allergy to any of the drugs use
- •Known Congenital heart disease.
结局指标
主要结局
To compare the effect of two doses of Dexmedetomidine on the incidence of emergence
时间窗: 0min ,10min ,20min ,30min ,40min after extubation
agitation in pediatric patients undergoing inguinal hernia surgeries under general anaesthesia
时间窗: 0min ,10min ,20min ,30min ,40min after extubation
with sevoflurane by using the PAED scale.
时间窗: 0min ,10min ,20min ,30min ,40min after extubation
次要结局
- 1. To study the recovery profile in terms of emergence time, extubation time, and(discharge time from the recovery room using the Steward recovery score.)
研究者
Dr Ankit
VMMC and SJH