Comparison of Thoracoscopic Talc Pleurodesis by Thoracic Epidural or General Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eugenio Pompeo, University of Rome Tor Vergata
ClinicalTrials.gov Identifier:
NCT01469728
First received: October 28, 2011
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Pleural Effusion
Procedure: Non-awake VATS talc pleurodesis
Procedure: Awake VATS talc pleurodesis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Study of Thoracoscopic Talc Pleurodesis Performed by Thoracic Epidural or General Anesthesia

Further study details as provided by University of Rome Tor Vergata:

Primary Outcome Measures:
  • Grade of perioperative medical care (PMC). [ Time Frame: participants are followed for the duration of hospital stay; average of 5 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: Postoperatively at 3h,12h and 24h ] [ Designated as safety issue: No ]
  • Perioperative changes in blood gases [ Time Frame: Imediately before operation, at end-procedure, postoperatively at 1h and 24h ] [ Designated as safety issue: No ]
    Ratio of arterial oxygen tension to fraction of inspired oxygen (PaO2/FiO2), arterial carbon dioxide tension (PaCO2)

  • 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 ] [ Designated as safety issue: No ]
  • Postoperative changes in spirometric variables [ Time Frame: Postoperatively at 3h,12h and 24h ] [ Designated as safety issue: No ]
    Forced expiratory volume in one second(FEV1), forced vital capacity (FVC), peak expiratory flow (PEF)

  • Morbidity [ Time Frame: from day of operation to discharge; average, 5 days ] [ Designated as safety issue: Yes ]
  • Hospital stay [ Time Frame: from day of operation to discharge; average, 5 days ] [ Designated as safety issue: No ]
  • Redo pleurodesis [ 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 ] [ Designated as safety issue: No ]
    Need of reoperation because of recurrence of the pleural effusion

  • Operative mortality [ Time Frame: from day of operation for up to 30 days postoperatively ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: November 2007
Study Completion Date: November 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Awake VATS
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Procedure: Awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
Active Comparator: Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
Procedure: Non-awake VATS talc pleurodesis
Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recurrent pleural effusion at the computed tomography occupying at least 1/3 of the hemithorax in patients with recent history of malignancy.
  • 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 of random assignment to treatment arm
  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01469728

Locations
Italy
Policlinico Tor Vergata University
Rome, Italy, 00133
Sponsors and Collaborators
University of Rome Tor Vergata
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eugenio Pompeo, Associate Professor, University of Rome Tor Vergata
ClinicalTrials.gov Identifier: NCT01469728     History of Changes
Other Study ID Numbers: 107/07, #20112
Study First Received: October 28, 2011
Last Updated: November 8, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by University of Rome Tor Vergata:
VATS
awake thoracic surgery
pleurodesis
talc
TEA
epidural anesthesia
Video-Assisted
Anesthesia Epidural

Additional relevant MeSH terms:
Pleural Effusion
Pleural Diseases
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014