The Comparison of Different Administration Routes of Pediatric Premedication-Single Center,Randomized，Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 主要终点
- Sedation Score
研究概览
简要总结
The study purpose is to compare the effect of different Administration Routes of Pediatric Premedication (including oral administration, intramuscular injection, rectal perfusion, intranasal).
详细描述
In this study, 80 cases of surgical or otolaryngology children undergoing elective surgery were divided into four groups：oral administration group, intramuscular group, rectal infusion group, intranasal group depending on the route of administration before anesthesia. By observing the difference of sedative effects, postoperative recovery, and postoperative psychological behavior among the four groups,compare the effect of four pre-anesthetic administration routes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent of children's parents;
- •Children patient in pediatric surgery and E.N.T. department;
- •surgery time 1 ~ 3 hours;
- •Aged between 1 and 7 years old;
- •American Society of Anesthesiologists (ASA)classification:class I~II;
排除标准
- •With cardiovascular and respiratory complications;
- •A history of the endocrine system;
- •A long history of application of sedative drugs;
- •Water and electrolyte balance disorder preoperatively;
- •Liver and kidney dysfunction;
- •Nervous system dysfunction;
- •High gastrointestinal obstruction;
- •Tracheoesophageal fistula, trachea foreign body, hiatal hernia, dysphagia;
- •Lung infection, atelectasis;
- •Congenital heart disease(CHD);
- •Severe malnutrition;
- •Traumatic or ischemia anoxic encephalopathy, high cranial pressure;
- •Anesthesia and surgery was conducted in 3 days;
研究组 & 干预措施
Oral administration
-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
干预措施: Oral administration (Other)
Oral administration
-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
干预措施: Anesthesia induction(midazolam,fentanyl,propofol,atracurium) (Drug)
Oral administration
-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
干预措施: Intubation (Procedure)
Oral administration
-Oral administration of a mixture at preoperative 30 minutes : ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
干预措施: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium) (Drug)
Intramuscular injection
-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
干预措施: Intramuscular injection (Other)
Intramuscular injection
-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
干预措施: Anesthesia induction(midazolam,fentanyl,propofol,atracurium) (Drug)
Intramuscular injection
-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
干预措施: Intubation (Procedure)
Intramuscular injection
-At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
干预措施: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium) (Drug)
Rectal perfusion
-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
干预措施: Rectal perfusion (Other)
Rectal perfusion
-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
干预措施: Anesthesia induction(midazolam,fentanyl,propofol,atracurium) (Drug)
Rectal perfusion
-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
干预措施: Intubation (Procedure)
Rectal perfusion
-At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
干预措施: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium) (Drug)
Dripping nose
-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
干预措施: Dripping nose (Other)
Dripping nose
-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
干预措施: Anesthesia induction(midazolam,fentanyl,propofol,atracurium) (Drug)
Dripping nose
-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
干预措施: Intubation (Procedure)
Dripping nose
-At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
干预措施: Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium) (Drug)
结局指标
主要结局
Sedation Score
时间窗: Try to break away from family membersan，an expected average of 3 min；Successfully break away from the family members and accept the face mask and venipuncture，an expected average of 5 min
次要结局
- Hemodynamic and anesthetic depth monitoring (Heart rate, blood pressure, pulse oxygen saturation, bispectral index(BIS)(From premedication to 10 min after extubation up to 4 hours)
- Postoperation recovery assess (Wake up agitation score (PAED)、Steward score 、Postoperative recovery score)(10 min after extubation)
- Stress index monitoring (The concentration of Plasma cortisol and blood sugar)(From anesthesia induction to 10 min after the start of surgery up to 30 min)
- Postoperative behavior assessment (Postoperative behavior scale (PHBQ)(1 day after the operation，7 day after the operation)