the Effect of Different Drugs and Infusion Ways on Degree of Comfort for Patients Undergoing Spinal Neoplasm Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale of Comfort level
研究概览
简要总结
To explore the effect of different drugs and infusion ways on degree of postoperative comfort.Patients undergoing spinal neoplasm surgery receive different patient controlled analgesia(PCA) drugs postoperatively,one group is sufentanil,the other is hydromorphone. Then each drug group will be divided into two subgroups according to the infusion way,intravenously,subcutaneously. During the patient controlled analgesia period, patients' degree of comfort,pain score,sleep quality, the degree of side reaction will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status I or II .
排除标准
- •history of severe heart, hepatic or renal disease,
- •history of chronic pain condition or opioid use,
- •body mass index (BMI) ≤18 or ≥30 kg/m2,
- •alcohol or drug abuse,
- •relevant drug allergy,
- •inability to properly describe postoperative pain,
- •inability to use PCA pump.
研究组 & 干预措施
sufentanil administration intravenously
The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.
干预措施: intravenous sufentanil (Drug)
sufentanil administration subcutaneously
The dose of sufentanil for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.
干预措施: subcutaneous sufentanil (Drug)
hydromorphone administration intravenously
The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.
干预措施: intravenous hydromorphone (Drug)
hydromorphone administration subcutaneously
The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.
干预措施: subcutaneous hydromorphone (Drug)
sufentanil and dexmedetomidine intravenously
The dose of sufentanil, dexmedetomidine,for patient-controlled analgesia is 3.0μg/Kg, dissolving in 100ml 0.9% normal saline (NS).The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5 ml/h, PCA dose 1ml, locking time 15 min.
干预措施: intravenous sufentanil and dexmedetomidine (Drug)
sufentanil and dexmedetomidine subcutaneously
The dose of sufentanil ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5 ml/h, PCA dose 1 ml, locking time 15 min.
干预措施: subcutaneous sufentanil and dexmedetomidine (Drug)
hydromorphone and dexmedetomidine intravenously
The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the hand vein.The parameters were set as background dose 1.5ml/h, PCA dose 1ml, locking time 15 min.
干预措施: intravenous hydromorphone and dexmedetomidine (Drug)
hydromorphone and dexmedetomidine subcutaneously
The dose of hydromorphone for patient-controlled analgesia is 0.2mg/Kg ,dexmedetomidine ,for patient-controlled analgesia is 3.0μg/Kg dissolving in 100ml 0.9%NS.The PCA pump is connected to the deltoid subcutaneously.The parameters were set as background dose 1.5ml/h, PCA dose 1 ml, locking time 15 min.
干预措施: subcutaneous hydromorphone and dexmedetomidine (Drug)
结局指标
主要结局
Visual Analogue Scale of Comfort level
时间窗: 48 hours after the use of PCA.
The participants' comfort level of the PCA."0" means extremely comfort, "10" means extremely discomfort.
次要结局
- Ramsay sedation score(6hours,12hours,24hours and 48 hours after the use of PCA.)
- The degree of nausea(6hours,12hours,24hours and 48 hours after the use of PCA.)
- The degree of dizziness(6hours,12hours,24hours and 48 hours after the use of PCA.)
- Pupil diameter(6hours,12hours,24hours and 48 hours after the use of PCA.)
研究者
Jun Wang
Professor
First Hospital of China Medical University