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Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT01677442
Recruitment Status : Unknown
Verified April 2012 by Jun Liu, Guangzhou Institute of Respiratory Disease.
Recruitment status was:  Recruiting
First Posted : September 3, 2012
Last Update Posted : September 3, 2012
Sponsor:
Information provided by (Responsible Party):
Jun Liu, Guangzhou Institute of Respiratory Disease

Study Description
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Brief Summary:
The purpose of this study is to compare results of general Video-assisted Thoracic Surgery (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a control group operated under general anesthesia with double-lumen endotracheal intubation.

Condition or disease Intervention/treatment Phase
Anaesthesia Video Assisted Thoracic Surgery Procedure: no-intubated thoracic epidural anesthesia Procedure: double-lumen endotracheal intubated anesthesia Phase 1 Phase 2

Detailed Description:

The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but also a quiet and wide operative field. That's why anaesthesia plays a critical role in thoracoscopic surgery.

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery
Study Start Date : July 2011
Estimated Primary Completion Date : July 2014
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: no-intubated group
Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
 Procedure: no-intubated thoracic epidural anesthesia
VATS under no-intubated thoracic epidural anesthesia
Active Comparator: intubated group
Active Comparator:double-lumen endotracheal intubated anesthesia
 Procedure: double-lumen endotracheal intubated anesthesia
VATS under double-lumen endotracheal intubated anesthesia


Outcome Measures
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Primary Outcome Measures :
  1. recovery time after intervention of each group [ Time Frame: 7 days ]
    the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay


Secondary Outcome Measures :
  1. incidence of complications [ Time Frame: 14 days ]

Other Outcome Measures:
  1. the inflammation level [ Time Frame: 7 days ]
    hemogram and some inflammatory markers


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 65 years old
  • 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:

  • Psychopath patients who cannot cooperate
  • 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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677442


Contacts
Contact: Jun Liu, MD. 13808880646 cuidavil@hotmail.com

Locations
China, Guangdong
the First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Fei Cui, MD.,PhD    08618902301212    4641121@qq.com   
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
Study Chair: Jianxing He, Ph.D, M.D. Guangzhou Institute of Respiratory Disease
Study Director: Jun Liu, M.D. Guangzhou Institute of Respiratory Disease
Principal Investigator: Fei Cui, Ph.D, M.D. Guangzhou Institute of Respiratory Disease
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Jun Liu, Director, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT01677442     History of Changes
Other Study ID Numbers: NTEA001
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: April 2012

Keywords provided by Jun Liu, Guangzhou Institute of Respiratory Disease:
nonintubated
anaesthesia
VATS

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs