Comparison of ketamine vs dexmedetomidine given prior to extubation for prevention of emergence agitation in pediatric patients undergoing tonsillectomy- A double blinded randomized control trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scale
研究概览
简要总结
•Emergence agitation (EA) is a phenomenon that includes restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. The incidence of Emergence agitation varies widely from approximately 0.25% to 90.5%, according to age, assessment tool used, definitions, anaesthesia techniques, type of surgery, and time at which Emergence agitation is assessed during recovery.
• The incidence of emergence agitation after sevoflurane anaesthesia estimated at 80%. Emergence agitation occurs most frequently in preschool children during the early stage of emergence from anaesthesia.
• Emergence agitation is commonly self-limited and happens within first 30 min of stay in a postanesthesia care unit (PACU) and also can lead to disconnection of monitoring devices or intravenous catheter, physical damage, falling, increase risk of bleeding.
•Ketamine is a N-methyl-D-aspartate (NMDA) receptor antagonist with a strong analgesic effect if given in less than anesthesia-induction dose . At small doses (<1 mg/kg), it does not cause respiratory depression and has little effect on the heart rate and blood pressure .
Dexmedetomidine is a highly selective α2 adrenergic receptor agonist which can produce pharmacological effects of anxiolysis, sedation, and analgesia without overt respiratory and circulatory inhibition in a routine dose. Dexmedetomidine can improve the cognitive function in children during recovery from general anesthesia and contributes to dose-dependent inhibition of emergence agitation after medical procedures .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Children aged ranged between 6 and 18 years belonging to ASA grade I scheduled for elective tonsillectomy.
排除标准
- •Children with Congenital anomalies, developmental problems, Inborn errors of metabolism, cerebral palsy, down syndrome.
- •Obese children with a risk of airway obstruction.
- •Patients with previous history of agitation after sevoflurane anesthesia and patients with respiratory distress of any cause.
- •Children with known allergy to any of the medications used.
- •Non willing patients.
- •Prolonged or any other complication during surgery.
结局指标
主要结局
To Compare the efficacy of ketamine (0.5mg/kg) vs dexmedetomidine (0.3mcg/kg) for prevention of emergence agitation using PAED scale
时间窗: Immediately after emergence and at 10-minute,20-minute and 30-minute.
次要结局
- To assess pain intensity using FLACC scale(After extubation ,10 minute,20 minute & 30 minute).
研究者
Dr Sauraya Pratap Singh
Heritage Institute of Medical Sciences ,Varanasi
