Effect of Single-dose Dexmedetomidine on Emergence Agitation and Postoperative Behavior Changes After Sevoflurane Anesthesia in Children
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
研究概览
简要总结
Emergence agitation (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.
详细描述
The high incidence of EA and postoperative behavioural changes has encouraged paediatric anaesthetists and researchers to study methods to improve the perioperative care of children. Dexmedetomidine is a selective alpha-2 receptor agonist with properties that make it attractive to pediatric use. It provides sedation and anxiolysis acting on these receptors in the locus ceruleus of the pons. It also exerts dose-dependent moderate primary analgesic effects through activation of alpha-2 adrenoreceptors in the dorsal spinal horn causing a subsequent decrease in substance P release. The study aims to explore whether a single low-dose dexmedetomidine in the perioperative period has a preventive effect on EA in children, and through short-term and long-term follow-up, to investigate the effect on post-hospitalization behavioural changes.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2-7 years old
- •American Society of Anesthesiologists（ASA） score of I or II
- •Selective ear, nose, and throat surgery under general anaesthesia with sevoflurane
排除标准
- •Emergency surgery
- •were intubated before induction of anaesthesia or not planned for extubation after anaesthesia
- •had critical illness with haemodynamic instability, active bleeding, cancer, cardiac diseases including arrhythmias, malignant hyperthermia
- •intellectual disability, or neurological illness with agitation-like symptoms
- •weighed more than 50 kg
- •were allergic to dexmedetomidine
- •The use of sedative or analgesic medications before surgery
研究组 & 干预措施
Dexmedetomidine group
the children received 0.5 μg/kg of intravenous dexmedetomidine over 10 minutes after induction of anesthesia
干预措施: Dexmedetomidine (Drug)
Control Comparator group
the children received 10ml saline over 10 minutes after induction of anesthesia
干预措施: saline (Drug)
结局指标
主要结局
Incidence of EA as assessed by the Pediatric Anesthesia Emergence Delirium (PAED) scale
时间窗: within 30 minutes after extubation in the post-anaesthesia care unit
Use the Pediatric Anesthesia Emergence Delirium (PAED) scale to record the incidence of EA.The score ranges from 0 to 20 points. A score of 10 or above is considered as EA.
次要结局
- Pain scores as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale(within 30 minutes after extubation in the post-anaesthesia care unit)
- Rescue analgesia and sedative drug consumption(within 30 minutes after extubation in the post-anaesthesia care unit)
- Incidence of adverse events(within 30 minutes after extubation in the post-anaesthesia care unit)
- Post-hospitalization negative behaviour changes as assessed by the Post Hospitalisation Behaviour Questionnaire (PHBQ) scale(1 day, 2 days,30 days post surgery)
研究者
Jin Dong Liu
Principal Investigator
Xuzhou Medical University