Intranasal Dexmedetomidine Decreases Emergence Delirium in Pediatric Patients After Sevoflurane Based General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.
研究概览
简要总结
The purpose of this study is to evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium during general sevoflurane anesthesia in a pediatric population receiving pressure equalization tubes in one or more ear.
详细描述
Emergence delirium has been described as a dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent, inconsolably crying, moaning, kicking or thrashing. The children can run the gambit from restlessness and incoherence to combative and psychotic. The incidence of emergence agitation or delirium is 80% after a procedure with sevoflurane-induced anesthesia.
Dexmedetomidine has been shown to have sedative and analgesic effects. In the pediatric population, it has been shown to provide sedation for radiographic procedures. Intravenously, it is has been shown to decrease emergence delirium following sevoflurane based anesthesia. The ability to administer a medication intranasally might solve the problem of emergence delirium and emergence agitation posed by the young patients undergoing myringotomy and tube placement.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA class 1 or 2 (healthy patient or acute illness)
- •Parental willingness to participate
- •Candidate for pressure-equalization tubes (PET) as determined by the ENT department
排除标准
- •ASA class 3 or 4 (chronic illness or life-threatening illness)
- •Parental refusal to participate
- •Significant liver disease by history
- •Allergy to dexmedetomidine or midazolam
- •Nasal deformity
- •Fever in the three days prior to surgery
- •Nausea or vomiting
- •History of hypertension
- •History of cardiac dysfunction/disorder
- •Diabetes mellitus
研究组 & 干预措施
saline
intranasal saline will be given 30 minutes prior to surgery
干预措施: saline (Drug)
dexmedetomidine
2 mcg/kg dexmedetomidine will be given intranasally 30 minutes prior to surgery
干预措施: dexmedetomidine (Drug)
结局指标
主要结局
To evaluate the use of intranasal dexmedetomidine to reduce the incidence of emergence delirium in general sevoflurane anesthesia.
时间窗: 2 hours post-surgery
次要结局
- Evaluate post-operative pain, emesis, and time to release from recovery.(2 hours post-surgery)