The Effect of Intranasal Dexmedetomidine Premedication in Children Undergoing Adenotonsillectomy Suffering From Recent Mild Upper Respiratory Tract Infection
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The incidence of peri-operative respiratory adverse effects (PRAE).
研究概览
简要总结
The purpose of this study is to detect the efficacy of intranasal dexmedetomidine as a premedication to general anesthesia in pediatric patients with respiratory comorbidities undergoing adenotonsillectomy.
详细描述
Respiratory comorbidities are associated with an increased incidence of peri-operative respiratory adverse effects (PRAE).
Upper and lower respiratory infections, as well as asthma, are common in children who are scheduled for adenotonsillectomy. When compared to healthy children, children with respiratory ailments have a three-fold increase in PRAEs.
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, Investigator)
入排标准
- 年龄范围
- 3 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children with recent mild URI or asthma.
- •aged from 3 to 10 years
- •ASA Physical Status II,
- •undergoing adenotonsillectomy
排除标准
- •Parental refusal of participation
- •Evidence of moderate to severe upper respiratory tract infection at time of presentation on the day of surgery
- •Lower respiratory tract infection
- •Congenital heart diseases
- •Known hypersensitivity to specific anesthetic agent
- •Liver or renal disease
研究组 & 干预措施
Intranasal
That will receive intranasal dexmedetomidine (1.5mcg/kg)
干预措施: Dexmedetomidine group (Drug)
control group
That will receive the same volume of 2 ml of intranasal normal saline
干预措施: control group (Other)
结局指标
主要结局
The incidence of peri-operative respiratory adverse effects (PRAE).
时间窗: From induction to emergence from general anesthesia.
All PRAE and the time of occurrence (induction, maintenance or emergence) will be recorded.
次要结局
- Hemodynamic stability(15 and 30 min after sedation)
- Sedating effects of this drug.(15 and 30 min after sedation)
- Ease of parental separation.(15 and 30 min after sedation)
- Face mask acceptance.(15 and 30 min after sedation)
研究者
Eman Ahmed Azzam
Resident of Anesthesia, Surgical Intensive Care and Pain Mrdicine
Tanta University