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临床试验/NCT06663488
NCT06663488已完成不适用

Thoracic Spinal Versus Thoracic Epidural Anesthesia for Patients with Chronic Obstructive Pulmonary Disease Undergoing Supine Percutaneous Nephrolithotomy for Management of Renal Stones. a Prospective Double-blind Randomized Clinical Trial.

Sohag University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
1st analgesic requirment

研究概览

简要总结

Owing to the elevated risk of perioperative comorbidities, chronic obstructive and restrictive pulmonary disorders can be a challenging task for the anesthetist. Endotracheal intubation and intermittent positive pressure ventilation (IPPV), two hallmarks of general anesthesia (GA), are known to increase the risk of serious complications such as barotrauma, laryngospasm, and bronchospasm. Patients who had neuraxial anesthesia had a lower rate of pulmonary and cardiac problems and deep venous thrombosis after surgery compared to those who received GA. Global Initiatives for Chronic Obstructive Lung Disease (GOLD) described COPD as a pulmonary disease with an inflammatory process that affects both the central and peripheral tracheobronchial tree, the pulmonary vasculature, and the pulmonary parenchyma. This persistent and cumulative process leads to the narrowing of the small airways, which is difficult to reverse, along with changes in the smooth muscle of the airway, increased secretion of mucus-secreting glands and goblet cells, and the development of perivascular pulmonary fibrosis. These changes contribute to the development of pulmonary hypertension and increase the workload on the right ventricle. Ultimately, COPD is characterized by the obstruction of airflow during expiration. When the small airway becomes inflamed, the condition is called "obstructive bronchiolitis," and when the lung tissue becomes destroyed, the condition is called "emphysema.". Impairment in ventilation and perfusion (V/Q) ratios and pulmonary mechanics come from air trapping and dynamic hyperinflation caused by obstruction in small airways.

Patients with COPD have a wide range of options for anesthesia, depending on illness stage, type of surgery, and length of operation. General anesthesia (GA) is known to increase the risk of problems for patients with COPD, especially when paired with endotracheal tube insertion and mechanical ventilation. Increased risk of hypoxemia and intra- and postoperative pulmonary complications; laryngospasm; bronchospasm; lung barotrauma; hemodynamic instability; hypercarbia; prolonged postoperative mechanical ventilation; and difficulty in weaning. To address these challenges, there has been a growing inclination towards employing various forms of regional anesthetic techniques whenever possible, including central neuraxial block. This approach aims to minimize the risks associated with general anesthesia and its potential complications, providing a safer alternative for COPD patients undergoing different types of surgical procedures. Regional blocking, as opposed to GA, has been found to improve pulmonary outcomes in patients with severe COPD and patients with normal lung function.

详细描述

The purpose of the current study is to identify, and evaluate the patient's outcome, and compare the use of either thoracic spinal anesthesia (TSA) or continuous thoracic epidural anesthesia (CTEA) as a single PNL anesthesia for stone kidney in patients with COPD.

Materials and methods:

After approval of the Scientific Research Ethical Committee, Faculty of Medicine, Sohag University, written informed consent will be taken from all patients.

Inclusion criteria:

  • One hundred patients 45-80 years of age, with ASA physical status classes (II and III) complaining of COPD scheduled for various electives (PNL) for renal stone. All patients knew that they had COPD with stages I-III (mild to severe airflow limitation) with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) less than 70% of the normal value.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA physical status classes (II and III) complaining of COPD scheduled for various elective (PNL) for renal stone.
  • All patients known that they had COPD with stages I-III (mild to severe airflow limitation) with forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) less than 70% of the normal value.
  • Exclusion criteria:
  • Patients reject neuraxial anesthesia and prefer GA.
  • Local back infection.
  • Lumbar or thoracic spine deformity.
  • Coagulopathy or platelet dysfunction.
  • Diabetic patients with peripheral or central neurological dysfunction.
  • Pulmonary artery systolic pressure greater than 50 mmHg.
  • Obesity (BMI >30).
  • ASA physical status class less than III.
  • PaCO2 of more than 45 mmHg and PaO2 of less than 60 mmHg on room air.
  • Patients with allergy to local anesthetic (LA) drugs.

排除标准

  • 未提供

结局指标

主要结局

1st analgesic requirment

时间窗: 24 hours

The time at which 1st analgesic was given

Respiratory monitoring

时间窗: preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery

Respiratory rate (rate/min)

次要结局

  • PaCO2(preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery)
  • PaO2(preoperatively (baseline values), intraoperatively at 30 min, 1 h, at end of surgery, and postoperatively at 1 h after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fouad Soliman

Principal investigator. Lecturer of Anesthesiology and ICU

Sohag University

研究点 (2)

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