CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Non-awake VATS talc pleurodesis +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01469728
NCT01469728Phase 2Completed

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

University of Rome Tor Vergata·interventional·Posted Nov 10, 2011·Updated Nov 10, 2011

In Brief

A Phase 2 clinical trial evaluating Non-awake VATS talc pleurodesis and Awake VATS talc pleurodesis for Pleural Effusion. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 10, 2011
Enrollment StartNov 1, 2007
Primary CompletionSep 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 14.6 years ago

Interventions

Non-awake VATS talc pleurodesisprocedure

Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

Awake VATS talc pleurodesisprocedure

Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.