Dexmedetomidine Infusion Versus Ketofol Infusion on The Incidence of Emergence Delirium in Children Undergoing Congenital Inguinal Hernia Repair: A Prospective Randomized Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of postoperative emergence delirium
研究概览
简要总结
The aim of this study is to compare the effect of dexmedetomidine versus ketofol on the incidence of the emergence delirium in children undergoing congenital inguinal hernia repair.
详细描述
Emergence delirium (ED) is a disturbance in a child's awareness or attention to his/her environment with disorientation and perceptual alterations including hypersensitivity to stimuli and hyperactive motor behaviour in the immediate post anesthesia period.
Propofol is a non-opioid, non-barbiturate, sedative-hypnotic agent with rapid onset and short duration of action [12]. Ketamine is a phencyclidine derivative classified as a dissociative sedative that provides analgesia and amnesia.
Combination of ketamine with propofol reduces the sedative dose of propofol. The complementary effects of this combination are supposed to produce lower toxicity compared to each drug alone through decreasing required doses. Ketofol; mixed ketamine and propofol has been shown to be effective in emergency room for procedural sedation and for induction for rapid sequence intubation [13,14]. This combination is also effective to prevent ED in pediatric patients undergoing simple surgical procedural in addition to the advantage of better hemodynamic stability.
Dexmedetomidine is a highly selective, alpha2-adrenergic receptor agonist that has been widely used for adult anesthesia and as a sedative in intensive care units. Dexmedetomidine is safe in children due to its hypnotic, analgesic, sedative, and anxiolytic effects. it has been shown to improve intraoperative hemodynamic stability, minimize responses to stimuli, and reduce the need for other anesthetic agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 5 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •60 children aged from 2 to 5 years
- •presented with congenital inguinal hernia
- •the American Society of Anaesthesiologists classification ASA I-II.
排除标准
- •Past medical history of mental illness or neurological illness.
- •Renal or hepatic diseases.
- •Severe hearing or visual impairment which may interfere with communication and physical decline.
- •Congenital heart disease.
- •History of allergy to any of the study drugs.
研究组 & 干预措施
Dexmedetomidine Group
干预措施: Dexmedetomedine (Drug)
Ketofol Group
干预措施: Ketofol (Drug)
Control Group
干预措施: isotonic saline 0.9% (Drug)
结局指标
主要结局
Incidence of postoperative emergence delirium
时间窗: 5 -15 minutes
Assessment of delirium using Pediatric Anesthesia Emergence Delirium (PAED) will be performed on arrival at the Post Anesthesia Care Unit (PACU)
次要结局
未报告次要终点
研究者
Nada Maged Shaheen
Resident of Anesthesia, Surgical Intensive Care and Pain Management ,Faculty of medicine ,Tanta University, Egypt
Tanta University
