Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Grade of perioperative medical care (PMC).
研究概览
简要总结
Video-assisted thoracoscopic surgery (VATS) talc pleurodesis is often carried out in patients with malignant recurrent pleural effusion to relieve symptoms and prevent recurrence.
General anesthesia and one lung ventilation is the standard type of anesthesia employed for VATS although recently, thoracic epidural anesthesia (TEA) in awake spontaneously ventilating patients is being increasingly employed to perform several cardio-thoracic surgery procedures in an attempt of minimize operative risks and facilitate resumption of daily-life activity.
The investigators have reasoned that for a simple and palliative procedure such as talc pleurodesis in cancer patients is, use of general anesthesia and one-lung ventilation might be considered a potential cause of morbidity and delayed recovery. The investigators have also hypothesized TEA could be considered an optimal type of anesthesia in this setting leading to a fast recovery a reduced overall workload in medical care.
In this single-center randomized study, the investigators have comparatively assessed the impact of awake TEA versus general anesthesia and one-lung ventilation on comprehensive results of VATS talc pleurodesis.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
- •Karnofsky performance status ≥ 50
- •ASA score II-III
- •Acceptance of the randomly assigned anesthesia protocol
- •Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
- •Absence of blood clotting disorders (INR < 1.5)
- •No contraindications to TEA
- •No neurological or psychiatric disturbance contraindicating awake surgery
排除标准
- •Patients refusal of random assignment to treatment arm
- •Patients refusal or noncompliance to TEA
- •Patients refusal or noncompliance to general anesthesia and one-lung ventilation
- •Unfavourable anatomy for TEA
- •Previous surgery of the thoracic spine
- •Coagulation disorders (thromboplastin time < 80%, prothrombin time > 40 sec, platelet count < 200/nL or bleeding disorders
结局指标
主要结局
Grade of perioperative medical care (PMC).
时间窗: participants are followed for the duration of hospital stay; average of 5 days
PMC is aimed at evaluating the overall workload in medical care throughout the the entire perioperative period and until discharge. PMC was computed as a comprehensive multidimensional variable including hospitalization time and extra-routine nursing/clinical/pharmacological requirements and costs(grades 1-3).
次要结局
- Operative mortality(from day of operation for up to 30 days postoperatively)
- Postoperative pain(Postoperatively at 3h,12h and 24h)
- Perioperative changes in blood gases(Imediately before operation, at end-procedure, postoperatively at 1h and 24h)
- Perioperative changes in cardiocirculatory variables including heart rate (HR) and mean arteial pressure (MAP)(Immediately before the operation, at end-procedure, postoperatively at 1h and 24h)
- Postoperative changes in spirometric variables(Postoperatively at 3h,12h and 24h)
- Morbidity(from day of operation to discharge; average, 5 days)
- Hospital stay(from day of operation to discharge; average, 5 days)
- Redo pleurodesis(From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause)
研究者
Eugenio Pompeo
Associate Professor
University of Rome Tor Vergata