Safety and Results of Thoracoscopic Lobectomy Using Nonintubated Anesthesia Versus Intubated General Anesthesia for Lung Cancer Patients.
试验速览
- 阶段
- 1 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Comparing the safety after intervention of each group.
研究概览
简要总结
The purpose of this study is to study the safety and results of thoracoscopic lobectomy using non-intubated thoracic epidural anesthesia versus intubated general anesthesia for lung cancer patients.
详细描述
Lung cancer is the leading cause of cancer death in Taiwan. Traditionally, open thoracotomy has been the standard approach for lung cancer surgery, including lobectomy and pneumonectomy. With the advance of thoracoscopic technique, thoracoscopic lobectomy has emerged as a reasonable option for the management of early-stage non-small cell lung cancer (NSCLC), and is supported by evidence-based treatment guidelines. Advantages of thoracoscopic lobectomy compared with thoracotomy include less postoperative pain, shorter hospitalization, and decreased postoperative pulmonary complications.
Traditionally, general anesthesia (GA) with one-lung ventilation using double-lumen endotracheal intubation has been considered mandatory in both open and thoracoscopic surgery. However, adverse effects of GA may occur after the operation, including ventilator-induced lung injury, impaired cardiac performance, postoperative nausea and vomiting, and residual neuromuscular blockade.
In order to reduce the adverse effects of GA, nonintubated anesthesia has been recently employed to perform thoracic surgery procedures including coronary artery bypass, management of pneumothorax, resection of pulmonary nodules and solitary metastases, lung volume reduction (LVR), and even transsternal thymectomy. The results achieved in these early series have been encouraging. In Taiwan, nonintubated thoracic surgery has also been performed at Taipei Veteran General Hospital in a high risk patient with satisfactory results.
The role of nonintubated anesthesia in thoracoscopic lobectomy is rarely investigated. There is a report showed that lobectomy using nonintubated anesthesia is safe and feasible, although only 3 cases were reported [13]. In our hospital, we also performed 6 thoracoscopic lobectomy using nonintubated anesthesia between August and October, 2009 with satisfactory results. Until now, the safety and effects of nonintubated anesthesia in thoracoscopic lobectomy has been unclear and comparison between nonintubated and intubated general anesthesia has never been reported. We hypothesize that nonintubated thoracoscopic lobectomy will be associated with a comparable oncological results, lower cardiopulmonary complications, and shorter intensive care unit (ICU) and hospital stays. To this end, we will compare safety and results of thoracoscopic lobectomy using nonintubated anesthesia versus intubated general anesthesia for lung cancer patients.
This study will be performed at National Taiwan University Hospital. A total of 100 patients will be included (50 patients in each arm).
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
- 25 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non-small cell lung cancer with clinical staging of I or II for whom thoracoscopic lobectomy is feasible.
- •Age between 25 and 80 years old
- •Tumor size < 5 cm without chest wall, diaphragm, or main bronchus invasion
- •Predicted FEV 1.0 > 60% or FEV1.0 > 1.5L
- •Organ Function Requirements:
- •Adequate hematological function (ANC > 1.5 x 109/L, platelets > 100 x 109/L)
- •PT, PTT<1.5X
- •Written inform consent
排除标准
- •Failed thoracic epidural catheter insertion
- •A history of previous epidural catheter insertion or ipsilateral thoracic operation
- •Signs of intrapleural adhesions
- •Pregnant or lactation female
- •ASA score greater than 3
- •Unfavorable airway or spinal anatomy judged by anesthesiologist
- •Sleep apnea
结局指标
主要结局
Comparing the safety after intervention of each group.
时间窗: 1 month
Comparing the complication and morbidity after intervention of each group
次要结局
- Short-term outcome(one month)
- Oncological outcome(5 years)
