The Effect of Propofol Versus Lidocaine on Emergence Agitation in Children Undergoing Tonsillectomy.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.
研究概览
简要总结
This study aim to compare the effect of intravenous propofol versus intravenous lidocaine on emergence agitation in children undergoing tonsillectomy or adenotonsillectomy under general anesthesia.
详细描述
Tonsillectomy is one of the common surgeries in children, which is associated with many morbidities such as postoperative pain, nausea, vomiting, bleeding, dehydration and emergence agitation .
Emergence agitation (EA) is a prevalent occurance following sevoflorane anesthesia , with an incidence of up to 80% , particularly among preschool children EA is characterised by a dissociated state of consciousness' in which the child displays irritability, anxiety , and inconsolable crying, kicking, or thrashing behavior Furthermore , EA in children can potentially be dangerous as it may lead to incidents such as falling out of bed , removal of surgical dressings , intravenous catheters , increase stress for healthcare providera and parents , higher costs due to prolonged recovery stay .³ The mechanism of EA remains unclear. The proposed risk factors of EA include age ,preoperative anxiety,, type of surgery, emergency operation, use of inhalational anesthetics , long duration of surgery.
Several pharmacological prophylactic interventions ,including opioids analgesics , benzodiazepines, α2-adrenergic receptor agonists such as clonidine , have been studied for their potential to reduce incedence of EA .
Propofol, short acting intravenous anesthetic, is known for smoother emergence and sedative properties. Lidocaine, administered intravenously, has analgesic, anti-inflammatory, and sedative effects. There is limited direct comparison between these two drugs specifically in pediatrc tonsillectomy with EA.
So, does intravenous lidocaine compared with propofol reduce the incidence and severity of emergence agitation in children undergoing tonsillectomy or adenotonsillectomy ?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective tonsillectomy operation
- •pediaterics between ( 4 : 7 ) years old
- •ASA I OR II
排除标准
- •emergency cases as bleeding tonsills
- •ASA III OR IV
研究组 & 干预措施
Group ( p ) recieve 1mg /kg of propofol
干预措施: Propofol (Drug)
Group ( L ) recieve 1.5 mg/kg of lidocaine
干预措施: Lidocaine %2 ampoule (Drug)
结局指标
主要结局
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using Pediatric Anesthesia Emergence Delirium (PAED) scale.
时间窗: Within 30 minutes after extubation
Pediatric Anesthesia Emergence Delirium (PAED) scale (range 0-20; higher scores indicate more severe agitation).
To compare the incidence and severity of emergence agitation (EA) between children receiving propofol and those receiving lidocaine using WATCHA scale
时间窗: Within 30 minutes after extubation.
Watcha agitation scale (range 0-4; higher scores indicate more severe agitation).
次要结局
- emergence time from anesthesia(Within 30 minutes after extubation.)
- peaked PAED scores(Within 30 minutes after extubation.)
- extubation time(Within 30 minutes after extubation.)
- post-operative pain using FLACC score(Within 30 minutes after extubation.)
- Hemodynamic effects as hypotention and bradycardia(Within 30 minutes after extubation.)
- Post operative nausea and vomitting(Within 30 minutes after extubation.)
研究者
Hesham Bahaa-eldin Mohamed
Resident doctor at anesthesia & ICU depatrtment
Assiut University