Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia
NCT ID: NCT01469728
Last Updated: 2011-11-10
Study Results
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Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2007-11-30
2010-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Awake VATS
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Interventions
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Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Eligibility Criteria
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Inclusion Criteria
* Karnofsky performance status ≥ 50
* ASA score II-III
* Acceptance of the randomly assigned anesthesia protocol
* Radiologic evidence of lung re-expansion after previous drainage/thoracentesis
* Absence of blood clotting disorders (INR \< 1.5)
* No contraindications to TEA
* No neurological or psychiatric disturbance contraindicating awake surgery
Exclusion Criteria
* Patients refusal or noncompliance to TEA
* Patients refusal or noncompliance to general anesthesia and one-lung ventilation
* Unfavourable anatomy for TEA
* Previous surgery of the thoracic spine
* Coagulation disorders (thromboplastin time \< 80%, prothrombin time \> 40 sec, platelet count \< 200/nL or bleeding disorders
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Eugenio Pompeo
Associate Professor
Locations
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Policlinico Tor Vergata University
Rome, , Italy
Countries
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References
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Pompeo E, Tacconi F, Mineo TC. Comparative results of non-resectional lung volume reduction performed by awake or non-awake anesthesia. Eur J Cardiothorac Surg. 2011 Apr;39(4):e51-8. doi: 10.1016/j.ejcts.2010.11.071.
Pompeo E, Tacconi F, Frasca L, Mineo TC. Awake thoracoscopic bullaplasty. Eur J Cardiothorac Surg. 2011 Jun;39(6):1012-7. doi: 10.1016/j.ejcts.2010.09.029. Epub 2010 Oct 25.
Vanni G, Tacconi F, Sellitri F, Ambrogi V, Mineo TC, Pompeo E. Impact of awake videothoracoscopic surgery on postoperative lymphocyte responses. Ann Thorac Surg. 2010 Sep;90(3):973-8. doi: 10.1016/j.athoracsur.2010.04.070.
Pompeo E, Tacconi F, Mineo TC. Awake video-assisted thoracoscopic biopsy in complex anterior mediastinal masses. Thorac Surg Clin. 2010 May;20(2):225-33. doi: 10.1016/j.thorsurg.2010.01.003.
Tacconi F, Pompeo E, Sellitri F, Mineo TC. Surgical stress hormones response is reduced after awake videothoracoscopy. Interact Cardiovasc Thorac Surg. 2010 May;10(5):666-71. doi: 10.1510/icvts.2009.224139. Epub 2010 Feb 23.
Tacconi F, Pompeo E, Fabbi E, Mineo TC. Awake video-assisted pleural decortication for empyema thoracis. Eur J Cardiothorac Surg. 2010 Mar;37(3):594-601. doi: 10.1016/j.ejcts.2009.08.003. Epub 2009 Sep 16.
Pompeo E, Mineo TC. Awake operative videothoracoscopic pulmonary resections. Thorac Surg Clin. 2008 Aug;18(3):311-20. doi: 10.1016/j.thorsurg.2008.04.006.
Pompeo E, Mineo TC. Two-year improvement in multidimensional body mass index, airflow obstruction, dyspnea, and exercise capacity index after nonresectional lung volume reduction surgery in awake patients. Ann Thorac Surg. 2007 Dec;84(6):1862-9; discussion 1862-9. doi: 10.1016/j.athoracsur.2007.07.007.
Pompeo E, Dauri M; Awake Thoracic Surgery Research Group. Is there any benefit in using awake anesthesia with thoracic epidural in thoracoscopic talc pleurodesis? J Thorac Cardiovasc Surg. 2013 Aug;146(2):495-7.e1. doi: 10.1016/j.jtcvs.2013.03.038. Epub 2013 Apr 17. No abstract available.
Other Identifiers
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#20112
Identifier Type: OTHER
Identifier Source: secondary_id
107/07
Identifier Type: -
Identifier Source: org_study_id