Comparison of Two Dosage of Remifentanil Infusion Combined with Propofol-based Total Intravenous Anesthesia in Percutaneous Vertebroplasty
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Adequate analgesia at the time of the trocar needle insertion
研究概览
简要总结
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Procedural analgesia and sedation (PAS) with propofol and remifentanil may provides optimal hypnotic and analgesic effects.
详细描述
Percutaneous vertebroplasty has become a mainstay in the management of osteoporotic and malignant vertebral fractures. Many anesthetic methods have been used in percutaneous vertebroplasty; however, there is no gold-standard method. Procedural analgesia and sedation (PAS) are one of the commonly used approaches. For its unique properties, including rapid onset, precise intraoperative control, and a fast recovery profile, remifentanil is preferable to other opioids administration in a target-controlled infusion (TCI) pump. Combination of remifentanil with propofol may improve sedation experience; however, it can increase a risk of respiratory depression. Moreover, propofol and remifentanil are often administered with 2 TCI pumps to, respectively, provide hypnotic and analgesic effects, which together are considered to be an ideal anesthetic technique.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) score of I-III patients receiving percutaneous vertebroplasty under procedural sedation and analgesia with remifentanil and propofol
排除标准
- •Age < 20 or > 80 years
- •ASA classifications > III
- •Pregnancy
- •Known allergies to opioids, propofol or any drugs used in the study
- •Emergency surgery
- •Patient refusal
研究组 & 干预措施
Group remifentanil of 1.0 ng/mL
Initial remifentanil effect-site concentration of 1.0 ng/mL
干预措施: Initial remifentanil effect-site concentration (Drug)
Group remifentanil 2.0 ng/mL
Initial remifentanil effect-site concentration of 2.0 ng/mL
干预措施: Initial remifentanil effect-site concentration (Drug)
结局指标
主要结局
Adequate analgesia at the time of the trocar needle insertion
时间窗: Time at the trocar needle placement
Remaining moveless at the time of the trocar needle insertion
Adequate analgesia at the time of the bone cement injection
时间窗: Time at the bone cement injection
Remaining moveless at the time of the bone cement injection
次要结局
- Hypotension at the time of the trocar needle placement(Time at the trocar needle placement)
- Hypotension at the time of the bone cement injection(Time at the bone cement injection)
- Apnea with desaturation at the time of the trocar needle placement(Time at the trocar needle placement)
- Apnea with desaturation at the time of the bone cement injection(Time at the bone cement injection)
- TCI pump adjustments at the time of the trocar needle placement(Time at the trocar needle placement)
- TCI pump adjustments at the time of the bone cement injection(Time at the bone cement injection)
- Numeric rating scale(Postoperative one hour)
研究者
Wei-Cheng Tseng
Principal Investigator
Tri-Service General Hospital