Awake Thoracic Epidural Anesthesia Versus General Anesthesia in Thoracotomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Assessment the change in pulmonary function
研究概览
简要总结
This study aims to compare awake thoracic epidural anesthesia and general anesthesia in thoracotomy.
详细描述
The severity of acute postoperative pain is a causative factor for chronic postsurgical pain, and it has been observed that the incidence of chronic postsurgical pain is very high after thoracotomy. Effective management of acute post-operative pain is a must in these patients.
Thoracic epidural analgesia (TEA) is used as an adjunct to general anesthesia (GA) in thoracic surgery. However, tthe horacic epidural blockade has been rarely utilized as a sole method to provide anesthesia for major thoracic procedures
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18 to 75 years old.
- •Both genders.
- •American Society of Anesthesiologists (ASA) physical status classification II or III.
- •Scheduled for thoracotomy.
排除标准
- •Difficult airway management,
- •Hemodynamically unstable patients, obesity (body mass index >30).
- •Absolute contraindication to thoracic epidural anesthesia such as (patient refusal, allergy to local anesthetics, coagulopathy, active neurologic disorders, skin infection at insertion site, uncooperative patients, uncontrolled cough, and unfavorable anatomy for thoracic epidural).
- •Neurological disorders: risk of seizure, unable to cooperate, intracranial mass or brain edema, extensive pleural adhesions or previous pulmonary resections, hypoxemia (PaO2 <60) or hypercarbia (PaCO2 >50)
- •Poor cardiac function (ejection fraction less than 50%).
- •Patients with bad pulmonary function tests.
研究组 & 干预措施
Awake thoracic epidural anesthesia group
Patients will preoperatively receive awake thoracic epidural anesthesia.
干预措施: Awake thoracic epidural anesthesia (Drug)
General anesthesia group
Patients will receive general anesthesia.
干预措施: General anesthesia (Drug)
结局指标
主要结局
Assessment the change in pulmonary function
时间窗: 24 hours postoperatively
The change in pulmonary function will be assessed using Forced vital capacity (FVC) will be recorded.
次要结局
- Heart rate(Till the end of surgery (Up to 2 hours))
- Mean arterial pressure(Till the end of surgery (Up to 2 hours))
- Degree of pain(48 hours postoperatively)
- Total morphine consumption(48 hours postoperatively)
- Time to 1st rescue analgesia(48 hours postoperatively)
- Incidence of adverse events(48 hours postoperatively)
研究者
Mohamed Elsaid Abdel Fattah
Lecturer of Anesthesia, Surgical ICU and Pain Management, Faculty of Medicine, National Cancer Institute, Cairo University, Egypt.
Cairo University