NCT01469728

Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
PROCEDURE	Non-awake VATS talc pleurodesis	Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
PROCEDURE	Awake VATS talc pleurodesis	Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.

Timeline

• Start date: 2007-11-01
• Primary completion: 2010-09-01
• Completion: 2010-11-01
• First posted: 2011-11-10
• Last updated: 2011-11-10

Locations

1 site across 1 country: Italy