The Efficacy and Safety of Opioid-free Anesthesia(OFA) for Non-small-cell Lung Cancer Resection and Its Underlying Clinical Value: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- acute postoperative pain scores
研究概览
简要总结
to investigate the efficacy and safety of opioid-free anesthesia for non-small-cell lung cancer resection and its underlying clinical value
详细描述
Opioids used to have its irreplaceable role in standard opioid-based anesthesia, yet with the help of hypnotics, local anesthetics, anti-inflammatory drugs, α-2 agonists and epidural techniques, opioid-free anesthesia (OFA) has been proved to be safe and feasible for non-cardiac major surgeries. Opioid-sparing anesthesia (OSA) is encouraged by the needs of enhanced recovery and recommended by the latest guidelines for anesthesia of lung surgery. According to previous studies, both opioid-sparing and opioid-free anesthesia would reduce the incidence of opioid-related adverse events and speed up the postoperative recovery to some extent, yet no studies ever are dedicated to compare these two different techniques.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •going through thoracoscopic lung surgery including lobectomy, segmentectomy, single or multiple wedge resection, and two of the above procedures combined;
- •able to complete the pain scoring face-to-face;
- •no cognitive dysfunction or history of anesthetic drug allergy;
- •ASA grade I-II
排除标准
- •psychological disorders
结局指标
主要结局
acute postoperative pain scores
时间窗: day2 postoperation
visual analog scale was used
occurrence of postoperative opioid-related adverse events
时间窗: day2 postoperation
occurrence of postoperative opioid-related adverse events
次要结局
- Pathologic results and TNM rating(within one month)
- occurrence of episodes of postoperative pain (VAS ≥4)(within 48hours)
- PCEA bolus consumption(within 48hours)
- need for rescue intravenous opioids or any type of painkiller(within 48hours)
- hospital length of stay and total hospital expenses(within 10days)
- relapse free survival and overall survival(within 5 years)