Use of a Remifentanil-propofol Mixture in Patients With Breast Cancer Undergoing Breast Cancer Surgery: a Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Frequency of TCI device adjustments
研究概览
简要总结
Co-administration of propofol and remifentanil is considered to be an ideal total intravenous anesthesia technique, which is widely used in induction and maintenance of general anesthesia. Remifentanil and propofol can be mixed in polypropylene syringes for one hour with a remaining concentration of 91% in small concentrations of remifentanil. However, delivery of remifentanil-propofol mixture by target-controlled infusion(TCI) for general anesthesia in surgical procedure has not been described. Breast cancer surgery ( including modified radical mastectomy and breast-conserving surgery) is a less time-consuming procedure for patients with breast cancer with one-hour duration in our hospital. This pilot study was to examine the merit of remifentanil-propofol mixture as a GA regimen for breast cancer surgery.
详细描述
Previous studies has described the feasibility and safety of remifentanil-propofol mixture use in sedation of pediatric patients undergoing magnetic resonance imaging or flexible fiberoptic bronchoscopy.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA II or III
- •age more than 18 years
- •scheduled for breast cancer surgery under general anesthesia.
排除标准
- •previously allergic to propofol or remifentanil
- •combining other surgical procedure leading to extended operative time
研究组 & 干预措施
Mix infusion using single TCI pump
participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump infusion
干预措施: Remifentanil-propofol mixture (Combination Product)
Separate infusion using two TCI pumps
participants receive total intravenous anesthesia with remifentanil and propofol separately by two TCI pumps infusion
结局指标
主要结局
Frequency of TCI device adjustments
时间窗: during procedure
Total times of TCI pump adjustment
次要结局
- Mean blood pressure(at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes)
- Patient satisfaction(the 1 day after operation)
- postoperative analgesia rescue(An average of 30 minutes after arriving at PACU)
- Total dose of remifentanil(At the end of surgery)
- Heart rate(at 5 minute intervals perioperatively throughout the procedure in an average of 60 minutes)
- Total dose of propofol(At the end of surgery)
研究者
Meng-Fu Lai
Resident physician
Tri-Service General Hospital