Effect of Two Different Doses of Intranasal Dexmedetomidine on the Incidence of Emergence Agitation in Children Undergoing Strabismus Surgery , A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of emergence agitation
研究概览
简要总结
Dexmedetomidine is a selective a-2 adrenergic agonist that provides sedative and analgesic effects. Intranasal dexmedetomidine has a slower and gradual onset compared to intravenous injection , with low incidence of nasal discomfort. Dexmedetomidine was tested at various doses and modes of administration, as well as different types of surgery and co-anesthetic drugs, as a single injection or continuous infusion. The authors have not agreed on the ideal clinical dose. The hypothesis is that intranasal dexmedetomidine 3mcg /kg will decrease the incidence of emergence agitation after strabismus surgery than dexmedetomidine 2 mcg/kg
详细描述
Strabismus surgery is typically performed under general anesthesia in pediatric patients. Pediatric patients undergoing strabismus surgery often experience emergence delirium (ED), with rates ranging from 40-86%.(1) ED includes confusion, crying, non-purposeful aggressive movements, and inconsolability during the early stages of recovery from general anesthesia (GA). Adverse effects of ED include increased risk of suture dehiscence, accidental removal of intravenous catheters, self-injury, longer postanesthesia care unit (PACU) stay, and undesirable postoperative behavior.(2,3) Preschool age, preoperative anxiety, pain, otorhinolaryngologic and ocular surgery, certain anesthetic drugs, and rapid awakening from anesthesia are all risk factors for ED.(4) Strabismus surgery is also strongly related to these characteristics. Our hospital performs numerous strabismus operations on preschool children daily. Preoperative anxiety affects up to 60% of young children undergoing surgery and can lead to ED.(5,6) Pharmacological medications have been used to lessen the prevalence of ED. Dexmedetomidine is a selective a-2 adrenergic agonist that provides sedative and analgesic effects. Intranasal dexmedetomidine has a slower and gradual onset compared to intravenous injection , with low incidence of nasal discomfort.(7,8, 9) Dexmedetomidine was tested at various doses and modes of administration, as well as different types of surgery and co-anesthetic drugs, as a single injection or continuous infusion. The authors have not agreed on the ideal clinical dose. The hypothesis is that intranasal dexmedetomidine 3mcg /kg will decrease the incidence of emergence agitation after strabismus surgery than dexmedetomidine 2 mcg/kg
Aim of the work:
The present study aims to compare the effect of use of two different doses of intranasal dexmedetomidine on incidence of emergence agitation after strabismus surgery.
Primary outcome:
• Incidence of emergence agitation using pediatric anesthesia emergence delirium ( PAED) scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 3-6 years, both sexes
- •ASA physical status class I , II.
排除标准
- •history of neurological and psychiatric disease
- •body mass index > 20 kg m-2
- •allergy to dexmedetomidine
- •patients on medical treatment which has any sedative effect
- •mentally retarded children
研究组 & 干预措施
high dex group
patients will receive 3 mcg/kg intranasal dexmedetomidine 45minutes before surgery
干预措施: high dex group (Other)
low dex group
patients will receive 2 mcg/kg intranasal dexmedetomidine 45minutes before surgery
干预措施: low dex group (Other)
结局指标
主要结局
Incidence of emergence agitation
时间窗: postoperative day 1
pediatric anesthesia emergence delirium ( PAED) scale.
次要结局
- Incidence of intraoperative hemodynamic changes(postoperative day 1)
- Modified Yale Preoperative Anxiety Scale (mYPAS) upon separation from parents(postoperative day1)
- PACU discharge time(postoperative day 1)
研究者
sarah mohamed
lecturer
Alexandria University