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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Policlinico Tor Vergata University
Rome, Italy
Grade of perioperative medical care (PMC).
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).
Time frame: participants are followed for the duration of hospital stay; average of 5 days
Postoperative pain
Time frame: Postoperatively at 3h,12h and 24h
Perioperative changes in blood gases
Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)
Time frame: 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)
Time frame: Immediately before the operation, at end-procedure, postoperatively at 1h and 24h
Postoperative changes in spirometric variables
Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)
Time frame: Postoperatively at 3h,12h and 24h
Morbidity
Time frame: from day of operation to discharge; average, 5 days
Hospital stay
Time frame: from day of operation to discharge; average, 5 days
Redo pleurodesis
Need of reoperation because of recurrence of the pleural effusion
Time frame: From date of operation until the date of redo pleurodesis or assessed every 6 months or until date of death from any cause
Operative mortality
Time frame: from day of operation for up to 30 days postoperatively
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.