Thoracic Spinal Versus Thoracic Epidural Anesthesia for Patients with Chronic Obstructive Pulmonary Disease Undergoing Supine Percutaneous Nephrolithotomy for Management of Renal Stones.
CompletedNot applicableNCT06663488
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 pos…
Study details
- Official title
- 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.
- Conditions
- Postoperative Pain
- Satisfaction with Care
- Interventions
- Procedure: Thoracic epidural anesthesia
- Procedure: Thoracic spinal anesthesia
- Sponsor
- Sohag University
- Start date
- 2023-08-15
- Primary completion
- 2024-10-01
- Sex
- All
- Age range
- from 45 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Countries
- Egypt
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06663488