Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
NCT ID: NCT01677442
Last Updated: 2012-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
500 participants
INTERVENTIONAL
2011-07-31
2015-07-31
Brief Summary
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Detailed Description
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General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse effects can derive from this type of anesthesia like intubation-related throat injury, ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid general anesthesia related risks.
Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in such a larger magnitude number and such operation varieties. The investigators hypothesize NTEA could result in less inflammations, lower incidence of complications, less dosage of antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason, the investigators will undertaken a randomized trial comparing results of general VATS operations under NTEA versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.
A total of 500 patients will be included. The study will be performed in the first affiliated hospital of Guangzhou Medical College.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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no-intubated group
Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
no-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
intubated group
Active Comparator:double-lumen endotracheal intubated anesthesia
double-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia
Interventions
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no-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
double-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia
Eligibility Criteria
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Inclusion Criteria
* signed inform consent
* Tumor size \< 6 cm without right or left bronchus invasion
* Predicted FEV 1.0 \> 60% or FEV1.0 \> 1.5L
* EF \> 50%
* PCO2 \< 50mmHg,PO2 \> 60mmHg（without uptaking oxygen）
Exclusion Criteria
* ASA score greater than 3
* A history of tuberculosis or other signs of intrapleural adhesions
* spinal malformation
* Hypovolemia or coagulation disorders
* BMI \> 30
* Unfavorable reasons judged by anesthesiologist or surgeon
18 Years
65 Years
ALL
No
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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Jun Liu
Director
Principal Investigators
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Jianxing He, Ph.D, M.D.
Role: STUDY_CHAIR
Guangzhou Institute of Respiratory Disease
Jun Liu, M.D.
Role: STUDY_DIRECTOR
Guangzhou Institute of Respiratory Disease
Fei Cui, Ph.D, M.D.
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Locations
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the First Affiliated Hospital of Guangzhou Medical College
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Fei Cui, MD.,PhD
Role: primary
Related Links
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Related Info
Other Identifiers
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NTEA001
Identifier Type: -
Identifier Source: org_study_id