A Comparative Study Between Thoracic Epidural Anesthesia in Non-Intubated Video-Assisted Thoracoscopes and the Conventional General Anesthesia With One Lung Ventilation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Perioperative changes in blood gases
研究概览
简要总结
Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and single lung ventilation. However, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.
详细描述
The aim of this study is to investigate the feasibility and the effect of Thoracic Epidural Anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying General Anesthesia with one lung ventilation.
Type of Study: Prospective randomized clinical study. Study Setting: This study will be conducted in Ain Shams University Hospitals..
Study Period: Expected for two years starting from 2019.
Sampling Method: Randomized sampling by a computer generated random numbers table.
Sample Size: 40 patients. Sample size was calculated using PASS 11 program for sample size calculation and according to the (Pompeo et al., 2004) study, the mean PaO2 perioperatively in the awake group = -3±1.5 mmHg and in the second group = -6.5±1.83 mmHg. Sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA less than or equal II.
- •The procedure expected to be completed within 2 hours.
排除标准
- •Patients with expected difficult airway management.
- •Hemodynamically unstable patients.
- •Persistent cough or high airway secretions.
- •Severe Emphysema or clinical signs of active infectious disease.
- •Hypoxemia (PaO2 <60 mmHg) or hypercarbia (PCO2 >50 mmHg)
- •Coagulopathy (INR >1.5).
- •Obesity (BMI >30 Kg/m 2 ).
- •Infection at the injection site, allergy to local anesthetics.
- •Neurological disorders: seizures, intracranial mass or brain edema.
研究组 & 干预措施
Group A
sole Thoracic Epidural Anesthesia
干预措施: Thoracic Epidural Anesthesia (Procedure)
Group B
General Anesthesia with One Lung Ventilation
干预措施: General Anesthesia with One Lung Ventilation (Procedure)
结局指标
主要结局
Perioperative changes in blood gases
时间窗: Imediately before operation, intraoperatively per hour, and postoperatively till 24 hours
Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2). Hypoxemia is defined as peripheral oxygen saturation (SpO2) \< 92% on room air with a need for oxygen supplementation.
次要结局
- Perioperative changes in heart rate(Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours)
- Perioperative changes in mean arterial pressure(Immediately before the operation, intraoperatively per hour, and postoperatively till 24 hours)
- The onset of ambulance.(During the 24 hours after regaining of full motor power)
- Number of episodes of Post Operative Nausea and Vomiting (PONV)(During the 24 hours postoperatively)
- Postoperative pain(Postoperatively at 3,12 and 24 hours)
- Postoperative opioid needs(Postoperatively during the 24 hours after regaining sensation)
- Hospital stay(from day of operation to discharge; average, 5 days)
研究者
Mohamed Reda Ashour
Assistant lecturer, Dept of Anesthesia, Intensive Care and Pain Management
Ain Shams University