Dexmedetomidine Versus Nalbuphine in Prevention of Emergence Agitation Following Adenotonsillectomy in Pediatrics
试验速览
- 阶段
- 1 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia
研究概览
简要总结
The aim of the present study is to compare the effect of IV infusion 0.5 µg/kg dexmedetomidine and IV 0.1 mg/kg nalbuphine in preschool children for prevention of emergence agitation after adenotonsillectomy under sevoflurane anesthesia.
详细描述
Consent will be obtained from legal guardian of children,patients will be randomized according to computer randomization to one of two groups, dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesia then 5ml of 0.9% normal saline IV ,nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
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, Care Provider)
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
- •Children of (American Society of Anesthesiologist)ASA physical status grade I or II.
- •Aged 2-5 years
- •Undergoing elective adenotonsillectomy.
排除标准
- •History of hypersensitivity to the studied drug.
- •Refusal of the legal guardian to participate in the study.
- •Severely agitated child at induction of anesthesia
- •Occurrence of postoperative bleeding at(Post Anesthesia Care Unit) PACU
研究组 & 干预措施
, Dexmedetomidine group(DEX group)
dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesa then 5ml of 0.9% normal saline IV ,
干预措施: Dexmedetomidine (Drug)
, Dexmedetomidine group(DEX group)
dexmedetomidine group (DEX)group who will receive 0.5 µg/kg dexmedetomidine diluted in 50 ml of normal saline 0.9% to be given by IV infusion over 10 minutes after induction of anesthesa then 5ml of 0.9% normal saline IV ,
干预措施: infusion pump (Device)
Nalbuphine group(NAL group)
nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
干预措施: Nalbuphine (Drug)
Nalbuphine group(NAL group)
nalbuphine group (NAL)group will receive IV infusion of 50 ml of 0,9%normal saline by IV infusion over 10 minutes then 0.1mg/kg nalbuphine diluted in 5ml of 0.9%normal saline IV after induction of anesthesia.
干预措施: infusion pump (Device)
结局指标
主要结局
postoperative agitation prevention in pediatrics after adenotonsillectomy under sevoflurane anesthesia
时间窗: stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks
during stay in postoperative care unit using pediatric anesthesia emergence delirium score (PAED) as score equal or more than 16/20 is considered presence of agitation. during stay in postanesthesia care unit,score will be documented every 10 minutes by recovery staff.
次要结局
- sedation in early postopertive time during child stay in postanesthesia care unit(stay in postoperative care unit till discharge of patient to ward.Time frame is up to 24 weeks)
研究者
Ashraf Elsayed Elagamy
Assisstant proffesor
Ain Shams University