The Effect of Combination of Dexmedetomidine and Sufentanil in Patient-controlled Intravenous Analgesia on Pediatric Patients Undergoing Scoliosis Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Postoperative opioid analgesic dosage
研究概览
简要总结
The primary purpose of this three-arm single center, randomized, subject and assessor blind, controlled clinical study is to evaluate the effect of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.
详细描述
The study is a single center, randomized, subject and assessor blinded, controlled clinical study.
Children who meet the inclusion/exclusion criteria will be evaluated. The patients will use a postoperative analgesic pump which is named as patient-control-analgesia (PCA) until the end of surgery with different dose of drugs. The control group will be set as using sufentanil only (0.05ug/kg/h infusion and 0.05ug/kg bolus). The experimental group will use sufentanil combined with different doses of dexmedetomidine. Low dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.05ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.05ug/kg dexmedetomidine bolus. High dose of dexmedetomidine PCA formula is 0.05ug/kg/h sufentanil with 0.1ug/kg/h dexmedetomidine infusion and 0.05ug/kg sufentanil with 0.1ug/kg dexmedetomidine bolus.
Then patients will be followed until they discharge.
The purpose of this trial is to evaluate the effect of of dexmedetomidine on patient-controlled intravenous analgesia after pediatric scoliosis orthopedics.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 1-14 years scheduled to receive scoliosis orthopedics under general anesthesia;
- •Weight is ±15% of standard weight (standard weight (kg) = height (cm) -100);
- •Informed consent signed.
排除标准
- •Allergy to dexmedetomidine;
- •Obvious abnormalities of heart, lung, liver, renal function and endocrine function;
- •Patients who can not cooperate with this trial.
研究组 & 干预措施
Sufen with low DEX
PCIA: continue with 0.05ug/kg/h sufentanil and 0.05ug/kg/h dexmedetomidine, 0.05ug/kg/h sufentanil and 0.05ug/kg/h dexmedetomidine bolus
干预措施: low dose of dexmedetomidine with sufentanil (Drug)
Sufen with high DEX
PCIA: continue with 0.05ug/kg/h sufentanil and 0.1ug/kg/h dexmedetomidine, 0.05ug/kg/h sufentanil and 0.1ug/kg/h dexmedetomidine bolus
干预措施: high dose of dexmedetomidine with sufentanil (Drug)
结局指标
主要结局
Postoperative opioid analgesic dosage
时间窗: 48 hours postoperatively
the total opioid consumption in PCIA postoperatively
次要结局
- Remedial analgesics dosage(48 hours postoperatively)
- Vomiting(72 hours postoperatively)
- LOS(through study completion, an average of 7 days postoperatively.)
- Patient satisfaction(48 hours postoperatively)
- Intraoperative opioid analgesic dosage(Intraoperative)
- Effective pressing times of PCIA(48 hours postoperatively)
- Sedation(72 hours postoperatively)
- Total pressing times of PCIA(48 hours postoperatively)
- Nausea(72 hours postoperatively)
- postoperative pain(48 hours postoperatively)