Effect of Three Doses of Sufentanil on Anesthesia Introduction and Recovery Quality in Pediatric Adenotonsillectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- adequate sufentanil dose
研究概览
简要总结
To study the effect of different doses of sufentanil on anesthesia induction and analgesia after tonsillectomy in children. According to the different doses of sufentanil used in anesthesia induction, the children were divided into 3groups. The vital signs during anesthesia, the recovery period of anesthesia and the complications after anesthesia were compared among the groups. The anesthetic effects and safety of sufentanil at different doses were discussed, which provided theoretical basis for clinical selection of the best drug dosage.
详细描述
Fifteen minutes before operation, midazolam 0.1 mg/kg was slowly intravenously injected. Five minutes later, the child entered the operating room. Pi, Narcotrend, blood pressure, ECG, SpO2 and body temperature were monitored. Penehyclidine hydrochloride 0.01 mg/kg, dexamethasone 0.1 mg/kg, propofol 3 mg/kg, sufentanil (0.3μg/kg, 0.4 μg/kg, 0.5 μg/kg) were given during anesthesia induction. cis-atracurium 0.15 mg/kg, using the required type of tube for tracheal intubation. Sevoflurane 1.0 MAC + remifentanil 0.15 ug/kg/min 50% oxygen was given during anesthesia maintenance. Effective analgesia was achieved by adjusting the dosage of remifentanil during operation.
The changes of vital signs including perfusion index, Narcotrend, Bp, HR, oxygen saturation were observed before anesthesia induction, immediately after tracheal intubation, during tonsillectomy and adenoidectomy during operation, after extubation and in the recovery room. Then record the recovery time, restlessness and pain score during recovery period, postoperative pain, nausea and vomiting and other complications.
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
- Single (Investigator)
盲法说明
Observers and patients were double-blind. Sufentanil was assigned by a specialist. Different doses of sufentanil were allocated in the same volume according to the weight of the child.
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 1-12 years,
- •ASA I-II grade;
- •selective adenotonsillectomy
- •BMI 18.5～23.9,
- •Sign informed consent
排除标准
- •Emergency surgery;
- •Abnormal liver and kidney function
- •severe dehydration and malnutrition or Hb < 10g/dl;
- •BMI <18.5 or <23.9;
- •Children with neurological disorders
研究组 & 干预措施
S1 group
Sufentanil 0.3 μg/kg was intravenously given during anesthesia induction
干预措施: Sufentanil Injection (Drug)
S2 group
Sufentanil 0.4 μg/kg was intravenously given during anesthesia induction
干预措施: Sufentanil Injection (Drug)
S3 group
Sufentanil 0.5 μg/kg was intravenously given during anesthesia induction
干预措施: Sufentanil Injection (Drug)
结局指标
主要结局
adequate sufentanil dose
时间窗: 24 hours
Adequate sufentanil dose is determined by Optimal intubation conditions and No hypotension or other severe side effects
次要结局
- cut off value of Pi for valid stress assessment(24 hours)
- Narcotrend index(24 hours)
- postoperative complications with different doses of sufentanil(7days)
研究者
aijun xu
associate professor
Tongji Hospital