Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- recovery time after intervention of each group
研究概览
简要总结
The purpose of this study is to compare results of general Video-assisted Thoracic Surgery (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.
详细描述
The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but also a quiet and wide operative field. That's why anaesthesia plays a critical role in thoracoscopic surgery.
General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse effects can derive from this type of anesthesia like intubation-related throat injury, ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid general anesthesia related risks.
Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in such a larger magnitude number and such operation varieties. The investigators hypothesize NTEA could result in less inflammations, lower incidence of complications, less dosage of antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason, the investigators will undertaken a randomized trial comparing results of general VATS operations under NTEA versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.
A total of 500 patients will be included. The study will be performed in the first affiliated hospital of Guangzhou Medical College.
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
- None
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
- •Age between 18 and 65 years old
- •signed inform consent
- •Tumor size < 6 cm without right or left bronchus invasion
- •Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L
- •EF > 50%
- •PCO2 < 50mmHg,PO2 > 60mmHg（without uptaking oxygen）
排除标准
- •Psychopath patients who cannot cooperate
- •ASA score greater than 3
- •A history of tuberculosis or other signs of intrapleural adhesions
- •spinal malformation
- •Hypovolemia or coagulation disorders
- •BMI > 30
- •Unfavorable reasons judged by anesthesiologist or surgeon
结局指标
主要结局
recovery time after intervention of each group
时间窗: 7 days
the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
次要结局
- incidence of complications(14 days)
研究者
Jun Liu
Director
Guangzhou Institute of Respiratory Disease